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992Banen gevonden

992 Banen gevonden 

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Plant Disease Surveillance and Prediction Scientist

Bayer

N/A, N/A
11 dagen geleden
N/A, N/A
11 dagen geleden

YOUR TASKS AND RESPONSIBILITIES

Your primary focus is to champion new technologies in plant disease monitoring and prediction for commercially important pathogens in vegetable crops. You will collaborate closely and lead cross-functional initiatives and teams with experts in data science, plant pathology, digital ag, as well as other technology fields. These teams will work together to support our vegetable product pipeline through the development of novel vegetable products that bring value to growers, processors, retailers and consumers

Responsibilities and goals you’ll own in this challenging position:

Identifying opportunities for technical innovation in plant disease surveillance and leading multiple complex scientific projects;
Developing data analysis platform to support large-scale epidemiological predictions;
Leading integration of data across the disease triangle (pathogen, host, environment) and epidemiological modeling to achieve robust disease prediction;
Developing effective methods for surveillance and risk assessment of emerging pathogens;
Working with technical project leads and other leaders to drive R&D and commercial strategy based on disease prediction insights;
Aligning research activities with team goals and broad business objectives;
Mentoring peers, coaching direct reports and extended team members in areas of technical expertise, developing employees on a day to day basis.

YOUR TEAM

A dynamic and inclusive work environment with “can do” attitude no matter which functional area. You will be part of a dedicated team of professionals all striving for turning our vision & mission into action. Our shared purpose is grounded on delivering better life through advancing health and nutrition by enabling access to safe, nutritious and delicious fruits and vegetables around the world. We do “science for a better life”.

In this role, you will work closely together with your colleagues in Vegetable R&D teams across the globe and you will be a member of the Vegetable Pathology leadership team. As building even stronger cross-functional and divisional collaborations is our priority, you will also closely interact with many stakeholders on a regular basis, including colleagues across Crop Science R&D teams such as Global Breeding, Small Molecules and Field Solutions, colleagues at Climate Corporation as well as external industry and academic partners.

ABOUT YOU

You are passionate about data and modeling, excited to develop predictive analytics capabilities and ready to lead strategic initiatives in disease surveillance and risk assessment through data-driven decisions. You have experience in project management and the ability to foster strong relationships and collaborations as well as effectively lead interdisciplinary and cross-cultural teams. Furthermore, your analytical and creative mindset allows you to simplify complexity, come up with novel solutions and innovate!

You bring:

PhD in plant pathology, or related field
Minimum of 1 year of experience in disease epidemiology
Broad expertise in disease epidemiology using traditional disease modeling and novel disease prediction methods
Background on statistics and data science
Experience with open-source programming languages
Demonstrated creativity in problem solving and ability to lead change
Outstanding analytical and communication skills
Strong initiative and results orientation

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Mechanical technician

Xelvin B.V.

HORST, LI
3 dagen geleden
HORST, LI
3 dagen geleden

Functiebeschrijving Ben jij een techneut met hands-on instelling? Ben je daarnaast graag dagelijks werkzaam met het samenstellen en assembleren van machines binnen de machinebouw? Lees dan snel verder! Grote kans dat onze functie als R&D technician iets voor jou is.
Iedere dag is een nieuwe uitdaging. Jouw kennis en expertise spelen een cruciale rol binnen het samenstellen en assembleren van nieuwe machines en installaties.
Tot je taken en verantwoordelijkheden behoren:

  • Het lassen, samenstellen en monteren van machineonderdelen;
  • Het afstellen en testen van deze machines;
  • Opsporen en verhelpen van storingen;
  • Het werken volgens een projectplanning;
  • Het meedenken over verbeteringen en oplossingen.

Functie-eisen Het is niet niks wat wij van jou vragen. Naast jouw kennis en expertise op het gebied van werktuigbouwkunde binnen een multidisciplinair team dien je als professional ook over de nodige communicatieve vaardigheden te beschikken. Aangezien je binnen een grote internationale organisatie aan de slag gaat zou het fijn zijn als je naast de Nederlandse taal tevens een woordje Engels spreekt.
Verder vragen wij:

  • Een MBO diploma richting werktuigbouwkunde;
  • Kennis van elektro en hydrauliek zou mooi meegenomen zijn;
  • Je hebt reeds ervaring als machinemonteur;
  • Bereidheid tot het werken op locatie bij klanten wereldwijd (aantal keer per jaar)
    Wat mag jij dan van Xelvin verwachten?
  • Een vaste job met toekomstperspectief;
  • Uitstekende arbeidsvoorwaarden, waaronder een op cao gebaseerd salaris, een 24/7 ongevallenverzekering en een aantrekkelijke pensioenregeling;
  • Persoonlijke coaching: we dagen je uit om aan de slag te gaan met persoonlijke ontwikkeling;
  • Opleidingsmogelijkheden om iedere dag jouw kennis uit te breiden.
    Ben jij enthousiast? Dan zie ik jouw sollicitatie graag tegenmoet! Mocht je nog vragen hebben sta ik je graag te woord.

Xelvin
Xelvin is een internationaal opererende organisatie. Verspreid over Europa zijn er 15 kantoren. We hebben een groot netwerk van professionals opgeleid van MBO, HBO tot Universiteit die vanuit een vast of flexibel dienstverband projecten uitvoeren voor toonaangevende opdrachtgevers.
Xelvin biedt haar medewerkers de beste balans tussen flexibiliteit en zekerheid en ruimte voor persoonlijke groei in een stimulerende en uitdagende werkomgeving. Xelvin is actief in de sectoren Technologie | Food, Chemie & Pharma | Bouw, Infra & Milieu | Energie & Water.
Solliciteren
Bent u geïnteresseerd? Neem dan contact op met Guy Tuncbilek, telefoonnummer 043-2041017 of verstuur uw sollicitatie per e-mail naar g.tuncbilek@xelvin.nl.

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Quality Systems Document Control Associate

CLS Services B.V.

Leiden, ZH
4 dagen geleden
Leiden, ZH
4 dagen geleden
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V. (Leiden, Nederland), we are searching for a Quality Systems Document Control Associate .


Keywords
  • Quality Documents
  • SOP's
  • Excel experience
  • Independant worker
  • Contact with customers


Profile
In your role as Quality Systems Document Control Associate you are responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Medical and Development QMS. You will contribute to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
Responsibilities:
  • Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards;
  • Ensure all Quality Documents meet required standards before processing documents in the Astellas Document Management System - Quality Document (ADMS QD) workflows;
  • Ensure impacted stakeholders are involved in the review of new and revised Quality Documents;
  • Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Astellas Document Management System - Quality Document (ADMS QD);
  • Support the development, review and delivery of training materials to provide to new users of the ADMS QD system;
  • Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards;
  • Support Document Control initiatives that lead to process improvements;
  • Respond to email inquiries and user support questions;
  • Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.

Who we're looking for
We are looking for an enthusiastic candidate with a Bachelor degree with some experience in the pharmaceutical industry. Preferable, you have experience within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline. You are proficient in working with Microsoft Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
Because of the intercontinetal team, it is important that you are a self-starter and that you can work independantly. Excellent communication skills are a must. You can multitask and shift workload according to the department/team priorities and you have strong planning and organizational skills.


Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.


Additional vacancy information
Reference:A2100040
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:Salary: max 2700
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Publication date:24-2-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)31 (0)88 22 77 555

Apply
Please apply online here for this job (Job Ref: A2100040). You can also check our other vacancies. You can also follow us on Twitter.
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Electrical Engineer (H/F)

Methode Electronics

Nuenen, NB
3 dagen geleden
Nuenen, NB
3 dagen geleden

Methode Electronics, Inc. (NYSE: MEI) is an international engineering company headquartered in Chicago, IL, with over 6,500 employees worldwide. Since being established in 1946 as a single-product manufacturer, Methode has since expanded its business into industrial design, manufacturing & distribution and professional services. Our company's vision is to utilize our technical capabilities to deliver unique, turnkey solutions that provide genuine value for our customers and its shareholders. As a global developer of custom engineered, application specific products and solutions, we are able to bring our innovative technologies closer to the customers and markets we serve. Methode’s business is managed on a segment basis, with those segments being, Automotive, Medical, Industrial and Interface. The Company has components in the primary end markets of the automotive, Big Data, white goods, aerospace & defense, consumer electronics and healthcare industries. For additional information, www.methode.com.

 

This assignment is for an Electrical Engineer (electronic system of opto-mechatronic products) responsible for work in the development of new customer specific products.  This person will be a member of core electronics design team. The projects are often different from project to project throughout the year.  In each project, this person will be a part of a development team, which would include Electrical Engineers, Mechanical Engineers, Software Engineers, Systems Engineers and lab technicians.  Creativity in problem solving, innovation in solutions developed, and teamwork are critical attributes for success in this assignment.  The successful candidate will work closely within the engineering team, the project team, off-site Methode production facilities, and sales.

Responsibilities

 

Product Development:

  • Develop innovative and creative electrical system design solutions for lighting products which results in a competitive advantage for the company
  • Test, analyze and package LED light solutions from concept or detailed specifications
  • Assemble electrical and electronic systems and prototypes according to design engineering or customer input based on knowledge of electrical principles
  • Build, calibrate, maintain, troubleshoot and repair electrical instruments and testing equipment
  • Develop and maintain test plans for the electronic components projects

 

Current Product Improvement:

  • Review current product and manufacturing processes for opportunities to improve cost, performance, reliability and manufacturability
  • Develop technical documentation including component selection, schematics, Gerber files, etc. for contract manufacturers.
  • Analyze and interpret test information to resolve technical issues in current applications.

Research & Development of New Technologies:

  • Research and present new technologies that will allow the company to stay on the leading edge of lighting system technology
  • Develop, demonstrate and present new lighting solutions for the commercial vehicle industry including interior general illumination, task lighting, accent lighting, backlighting and exterior lighting
  • Fully understand the characteristics and measurement techniques of LED products
  • Develop design guidelines and tools to support customers designing LED’s into their lighting systems
  • Conduct optical analysis for various LED-based lighting system

Qualifications

  • Bachelor degree or higher in Electrical Engineering with 5+ years of experience in designing electrical systems and solutions with LED sources or automotive lighting
  • 3+ years experience design and development of board level electronics circuit design (analog and digital), schematics, component selection and manufacturing.
  • Expert skills in client interaction and design support of LED applications
  • Analytical skills to identify market trends and opportunities
  • Knowledge of Altium, LTspice, Atmel Studio or similar software
  • Excellent organizational skills
  • Ability to work in a fast paced environment
  • Ability to effectively multi-task, be self-motivated and work independently or as part of a team.
  • Must possess good written and verbal communication skills with the ability to communicate clearly with technical and non-technical personal

 

 

Prefer knowledge in the following areas:

  • Extensive knowledge in opto-electronics and high power LED’s desired
  • Experience in design for human factor and ergonomic interaction
  • Regulatory requirements as they may apply to new product development, such as ECE, SAE, FMVSS and ASTM requirements.
  • Knowledge of quality concepts, including TS16949, continuous improvement, lean manufacturing, etc.
  • Ability to design and implement technical documents for project specifications, proposals, cost analysis
  • Good presentation skills: Ability to clearly and effectively communicate complex designs to other functional groups.
  • Problem solving skills: Able to clearly identify the problem to be solved and communicate corrective actions. 
  • Ability to travel up to 10% of the time, both domestically and internationally 

 

Methode Electronics is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, genetic information and other legally protected characteristics.

 

Interested applicants should send their cv in English to careers@methode-eur.com

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PV Compliance Manager

CLS Services B.V.

Leiden, ZH
4 dagen geleden
Leiden, ZH
4 dagen geleden
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V. (Leiden, Nederland), we are searching for a PV Compliance Manager.


Keywords
  • Pharmacovigilance
  • Safety Database
  • Root Cause Analysis
  • Audit/inspection


Profile
As (Associate) PV Compliance Manager, you will assist with the continuous monitoring of PV compliance, submission timeliness and quality metrics, including detection of negative patterns and trends, in close collaboration with internal and external stake holders (Regulatory Affairs, Quality Assurance, Business Partners). You support the preparation of PV metrics reports and presentations that include performance indicators that provide feedback to functional PV groups. You will work in close contact with people in the US, EU and Japan, and you will represent the compliance team during audits/inspections, mostly via telephone or video.



Who we're looking for
The ideal candidate has 3-6 years of experience in Pharma Quality and/or Compliance. You should have experience with Pharmacovigilance, PV Safety Databases, case processing and with performing Root Cause Analysis. As you will represent the Compliance team during audits and inspections, relevant experience is also a necessity. We are looking for someone who is a good listener and has strong communication and presentation skills. Are you the pro-active team player we are looking for?

Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.


Additional vacancy information
Reference:A2100039
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
WO/MSc.
Employment terms:Salary: 3500 - 5000
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Contract for at least 1 year, with the option to extend yearly.
Publication date:24-2-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)31 (0)88 22 77 555

Apply
Please apply online here for this job (Job Ref: A2100039). You can also check our other vacancies. You can also follow us on Twitter.
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Affiliate Support Manager

CLS Services B.V.

Leiden, ZH
13 dagen geleden
Leiden, ZH
13 dagen geleden
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V. (Leiden, Nederland), we are searching for an Affiliate Support Manager.


Keywords
  • Pharmacoviliance
  • Drug Safety Officer
  • Regulatory (regional / global)
  • Excellent communication
  • Problem solver


Profile
In this role, you are responsible for the day-to-day interactions with the Affiliate Drug Safety Officers (DSO) to ensure all Affiliate local PV systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements and Astellas policies and procedures.
You will have frequent interactions with DSOs, Affiliates colleagues, DSO/Affiliate Management, QPPV, PVQA colleagues so excellent communication skills and building good relationships are key.
Responsibilities:
  • Serve as first point of contact for all DSOs, globally;
  • Monitor affiliate performance and oversees training of Affiliate staff;
  • Ensure audit and inspection readiness of Affiliates;
  • Develop, oversee and implement (associated) CAPAs as the performance of the PV Affiliates has a direct impact on the Astellas PV system and compliance;
  • Develop and review regional QDs for consistency with regional/global regulatory requirements, SOPs and Astellas' expectations;
  • Ensure delivery of training to DSOs;
  • Monitor DSO performance based on predefined KPI;
  • Initiate and manage process improvement projects related to Affiliate procedures;
  • Ensure training requirements for DSOs are kept up to date;
  • Interact with DSO and other staff for implementation of PV-related regional and/or global procedures.

Who we're looking for
The ideal candidate has a BSc. or MSc. degree and at least 5 years of relevant experience. We are looking for a technical expert with an in-depth understanding of all aspects of PV and related disciplines. You have a strong industry mindset and are willing to travel up to 50% (after Covid).
You like to solve complex problems in a creative way and communicates excellent with partners and different departments.
Are you the experienced PV candidate we are looking for?


Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.


Additional vacancy information
Reference:A2100029
Contract:Temporary contract with CLS Services
Education:WO/MSc.
HBO/BSc.
Employment terms:Salary: >3500
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Publication date:12-2-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)31 (0)88 22 77 555

Apply
Please apply online here for this job (Job Ref: A2100029). You can also check our other vacancies. You can also follow us on Twitter.
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Laboratory Technician Cell Biology

Dümmen Orange The Netherlands B.V.

De Lier, ZH
2 dagen geleden
De Lier, ZH
2 dagen geleden

Dümmen Orange is the world’s largest breeder and propagator of cut flowers, bulbs, tropical plants, pot plants, bedding plants and perennials. For our Research & Development department, section Cell Biology & Tissue Culture, in De Lier we are looking for a Laboratory Technician Cell Biology.
Job objective
Our organization grows and flourishes. This results in a fast-changing and, therefore, challenging environment.

As Laboratory Technician you will actively participate in routine Tissue Culture activities within our Technology Application domain. The position offers exposure to the state-of-the-art cell biology and tissue culture technologies applied to a wide variety of ornamental crops in a competitive and dynamic environment. You will actively take part in a young and dynamic team; good communication skills and team-player mentality are valued in all our lab personnel. The reporting line is directed to Team Lead In Vitro.

Your tasks and responsibilities
You will have the following responsibilities and will perform the associated tasks to fulfil them:
•    Efficient and timely execution of routine activities like media preparation, multiplication and maintenance of stock plants, shipment etc;
•    Take part in processing different running projects e.g. embryo rescue, meristem culture, organogenesis;
•    Following process guidelines to achieve the best quality;
•    Assisting with Protocol applications and process execution;
•    Verbal and written report on progress;
•    Initiation of diagnostic testing by preparing and sending samples to diagnostic laboratory;
•    Supporting the Technology Application team with planning, organization, communication and administration.
Your profile
•    Vocational (or B.Sc.) degree in Life Sciences and/or Laboratory applications;
•    Proven experience with several of the techniques described above. Plant tissue culture experience is a plus;
•    Excellent interpersonal and communication skills;
•    Team player mentality;
•    Excellent command of the Dutch and English language.
We offer
Dümmen Orange has great global ambitions. Innovation, technology and quality are high priorities. This results in a challenging working environment in which you can develop yourself. Dümmen Orange offers its employees plenty of room for personal growth and development. We have an informal and easy accessible working environment in which cooperation is very important.
Dümmen Orange  
Dümmen Orange is the world’s largest breeder and propagator of flowers and plants. Its annual turnover is about 350 million euro. The company employs over 7.300 employees worldwide. In addition to a large marketing and sales network, Dümmen Orange has a diversified network of specialized production sites. The key to Dümmen Orange’s success is a broad and deep product range, supported by a global supply chain. The company embraces its social responsibilities and invests in the health, safety and personal development of its staff.

Your application
Click on the button below to apply for this job. If you have questions about the job, you can contact Mehdi Massoumi (Team lead In Vitro), via +31 174 540 100.   

Acquisition with reference to this advertisement will not be appreciated.

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Policy Advisor Transmission Services

TenneT B.V.

GE, GE
3 dagen geleden
GE, GE
3 dagen geleden

Functieomschrijving


What do you do as a policy maker?• You research and follow developments in the field of transmission services based on (European) relevant laws and regulations• You anticipate and advise on embedding changes in regulations in the organization.• You make policy and establish frameworks in the field of transmission services and you are also responsible for the implementation.• You lobby among policy makers and maintain close contacts in the chain with the other involved TenneT departments• You translate developments in the energy transition into consequences for energy transport and devise concepts for business operations, thereby identifying opportunities and risks.• You take account for the internal position with regard to relevant regulations and political developments and propagate this position internally / externally.• You develop and test policy within relevant projects (for example: implementation of European network codes).• You represent TenneT in national and international consultations such as ENTSO-E and other European working groups.



What do we expect from you?• You have an university degree, with a background in electrical engineering.• You are analytically strong and have a great conceptual mind.• You are willing to travel, because sometimes there are meetings abroad.Which competences do you bring?• The following competencies are well developed for you: result orientation, flexibility, initiative, communication and advice skills.• You are a real team player, a self-starter, who has a positive critical attitude• You are environmentally sensitive and you dare to speak out.• It is an advantage if you have knowledge and experience in the energy sector, especially in the field of energy transport.• You have excellent writing skills in both Dutch and English and preferably a good command of German


Wat kun je verwachten?

TenneT offers a challenging and responsible function within an innovative and dynamic international working environment. We offer a competitive salary package (Cao TSO job level 8/9) with excellent secondary benefits as well as good training and development possibilities. Duty station for this function is Arnhem.An assessment can be part of the application procedure.At entry, TenneT performs a Pre-Employment Screening.Please send your application and CV in English.

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Director, Global R&D QA - Qualified Person

InCyte

30+ dagen geleden
30+ dagen geleden

Job Summary (Primary function)

The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.

Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.

As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.

Essential Functions of the Job (Key responsibilities)

EU/EEA IMP Qualified Person responsibilities include:
Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
Perform GMP/GDP audits and Mock PAIs
Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
Support withdrawal of IMPs
Negotiate QA agreements
Represent Incyte Global QA in cross-functional project team meetings
Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
Collaborate with external partners QA, Responsible Persons (RPs) and QPs
Review regulatory submission documents such as INDs/IMPDs as well as Incyte s responses to Health Authorities requests and/or questions
Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
Develop, review and approve standard operating procedures

Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.

Graduate, preferably in Chemistry, Pharmacy or Biological Science;
Wide range of technical knowledge and experience within the pharmaceutical industry;
Substantial previous Quality Assurance experience;
Excellent scientific and technical knowledge;
Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
Up to date knowledge of cGMP, cGDP regulations;
Team player and ability to work with remote teams;
English fluency written and spoken (the company language);
Strong verbal and written communication skills with well-structured communication and presentation ability;
Strong interpersonal skills;
Ability to travel 15-20% or more as needed.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.

  1. the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.

  1. the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

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Director, Global R&D QA - Qualified Person

Incyte Corporation

30+ dagen geleden
30+ dagen geleden

Job Summary (Primary function)

The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.

Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.

As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.

Essential Functions of the Job (Key responsibilities)

• EU/EEA IMP Qualified Person responsibilities include:
• Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
• Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
• Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
• Perform GMP/GDP audits and Mock PAIs
• Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
• Support withdrawal of IMPs
• Negotiate QA agreements
• Represent Incyte Global QA in cross-functional project team meetings
• Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
• Collaborate with external partners QA, Responsible Persons (RPs) and QPs
• Review regulatory submission documents such as INDs/IMPDs as well as Incyte’s responses to Health Authorities requests and/or questions
• Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
• Develop, review and approve standard operating procedures

Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.

• Graduate, preferably in Chemistry, Pharmacy or Biological Science;
• Wide range of technical knowledge and experience within the pharmaceutical industry;
• Substantial previous Quality Assurance experience;
• Excellent scientific and technical knowledge;
• Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
• Up to date knowledge of cGMP, cGDP regulations;
• Team player and ability to work with remote teams;
• English fluency written and spoken (the company language);
• Strong verbal and written communication skills with well-structured communication and presentation ability;
• Strong interpersonal skills;
• Ability to travel 15-20% or more as needed.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.

  1. the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.

  1. the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Geplaatst op

11 dagen geleden

Beschrijving

YOUR TASKS AND RESPONSIBILITIES

Your primary focus is to champion new technologies in plant disease monitoring and prediction for commercially important pathogens in vegetable crops. You will collaborate closely and lead cross-functional initiatives and teams with experts in data science, plant pathology, digital ag, as well as other technology fields. These teams will work together to support our vegetable product pipeline through the development of novel vegetable products that bring value to growers, processors, retailers and consumers

Responsibilities and goals you’ll own in this challenging position:

Identifying opportunities for technical innovation in plant disease surveillance and leading multiple complex scientific projects;
Developing data analysis platform to support large-scale epidemiological predictions;
Leading integration of data across the disease triangle (pathogen, host, environment) and epidemiological modeling to achieve robust disease prediction;
Developing effective methods for surveillance and risk assessment of emerging pathogens;
Working with technical project leads and other leaders to drive R&D and commercial strategy based on disease prediction insights;
Aligning research activities with team goals and broad business objectives;
Mentoring peers, coaching direct reports and extended team members in areas of technical expertise, developing employees on a day to day basis.

YOUR TEAM

A dynamic and inclusive work environment with “can do” attitude no matter which functional area. You will be part of a dedicated team of professionals all striving for turning our vision & mission into action. Our shared purpose is grounded on delivering better life through advancing health and nutrition by enabling access to safe, nutritious and delicious fruits and vegetables around the world. We do “science for a better life”.

In this role, you will work closely together with your colleagues in Vegetable R&D teams across the globe and you will be a member of the Vegetable Pathology leadership team. As building even stronger cross-functional and divisional collaborations is our priority, you will also closely interact with many stakeholders on a regular basis, including colleagues across Crop Science R&D teams such as Global Breeding, Small Molecules and Field Solutions, colleagues at Climate Corporation as well as external industry and academic partners.

ABOUT YOU

You are passionate about data and modeling, excited to develop predictive analytics capabilities and ready to lead strategic initiatives in disease surveillance and risk assessment through data-driven decisions. You have experience in project management and the ability to foster strong relationships and collaborations as well as effectively lead interdisciplinary and cross-cultural teams. Furthermore, your analytical and creative mindset allows you to simplify complexity, come up with novel solutions and innovate!

You bring:

PhD in plant pathology, or related field
Minimum of 1 year of experience in disease epidemiology
Broad expertise in disease epidemiology using traditional disease modeling and novel disease prediction methods
Background on statistics and data science
Experience with open-source programming languages
Demonstrated creativity in problem solving and ability to lead change
Outstanding analytical and communication skills
Strong initiative and results orientation