Meest populaire vacatures

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179 Banen gevonden 

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Quality Manager & QA lead

Checkmark Labrecruitment

Tilburg, NB
21 dagen geleden
Tilburg, NB
€3k - €6k Per maand
21 dagen geleden
€3k - €6k Per maand
Waar ga je aan de slag - Where will you work

International company focused on advances in bioprocessing: high-value products and flexible solutions that address critical steps in the production of biologic drugs.

Wat ga je doen - What will your job be

As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis.
As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products

We are looking for two professionals in Quality: a Quality Manager and a Quality Assurance (QA) lead:

As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis.

  • Manage the daily Quality activities of column products from incoming raw material release through batch record review and release of finished goods. Manager of the Quality team within the production site Breda.
  • Establish and maintain a QC microbiology laboratory by building a robust microbiological system through ISO cleanroom cleaning validations, RODI water monitoring, and environmental monitoring and trending
  • Lead/administer audits of systems, processes and products to ensure compliance with ISO 9001 and customer requirements and compliance to the Quality System
  • Design, compile, analyze, trends and issue QA and QC performance metrics reports. Present summaries to senior management team during e.g. Management Reviews
  • Manage and develop QA and QC staff members; plan and implement QA and QC resources to support quality related activities
  • Member of the of the local Management Team

As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products. As a QA lead you will report to the Quality Manager.

  • Manage the Quality Documentation System and archival process, maintain employee training.
  • Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews.
  • Work with subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances and complaints.
  • Assist with compliance audits (customer, supplier, internal, external).
  • Manages daily schedule and communicates with peers and management for completion of tasks associated with product release.
  • Gathering of KPIs for weekly and monthly senior management meetings.


Wat vragen wij - What are we looking for

For this position as a Quality Manager we are looking for a bachelor or master candidate in Life Sciences with at least 7 years of experience in Quality (eg ISO9001)   

  • You have at least 3-5 years of experience mentoring and supervising direct reports, this can be in a manager or team lead role
  • Experience leading Quality audits both internally and externally; lead auditor certificate preferred
  • Experience with LEAN implementation strongly preferred
  • Experience with SAP and EDMS
  • Enthusiastic, team player, collaborative across all departments to achieve the common goals
  • Affinity to work in a high paced start-up environment, which means being flexible, being able to deal with uncertainty and changes of direction and work and thrive in a highly dynamic environment.

For the QA lead we are looking for a bachelor/master candidate with a degree in Life Sciences

  • You have at least 5 years’ work experience within Quality Assurance in an ISO 9001 certified facility or equivalent.
  • Internal auditor certification is preferred.
  • Experience and knowledge of IT software platforms that support Quality Management Systems.


Wat hebben we te bieden - What do we offer

  • Both positions are long term positions, starting with a 12 months contract at the hiring company
  • Competitive remuneration package, including a yearly bonus, non-contributory pension and partial compensation on your personal health insurance
  • Full-time position
  • Dayshift

Wil je meer weten - More information

For more information please contact Na Rae de Jong: 088 00 211 23 or narae@checkmark.nl or Talel Lakhal: 088-0021127
Vacancy: 6902

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Biologisch Laborant QC

Balans Uitzendburo

NB
7 dagen geleden
NB
2.12507k - 2.12507k
7 dagen geleden
2.12507k - 2.12507k
Functieomschrijving

In de functie van Biologisch Laborant ben je verantwoordelijk voor:
- Het uitvoeren, rapporteren en controleren van QC testen aan de hand van ELISA, PCR en Celkweek;
- Verwerking van resultaten en daar mogelijk data analyses op los laten;
- Deelname aan overleggen en verbeterprojecten;

Functie-eisen

Om in aanmerking te komen voor de functie van Biologisch Laborant beschik je over:
- Een afgeronde MLO4 of HLO biologisch of biomedische opleiding;
- Ervaring en Kennis van ELISA, PCR en celkweek is een vereiste;
- Goede communicatieve eigenschappen in zowel Nederlands als Engels;
- Een verantwoordelijke en pro-actieve houding;

Sollicitatieprocedure

Dit betreft een functie in Oost-Brabant in de omgeving van Haps voor minimaal 40 uur in de week in dagdienst. Ben jij geïnteresseerd in deze functie?
Neem dan direct contact op met Esther Wijtzes-Hurkmans op telefoonnummer 088 – 89 00 835 of per e-mail esther.wijtzes-hurkmans@balans.nu. Zij staat je graag te woord!
Werk maken van dromen?
Wij hebben vele vacatures openstaan voor uiteenlopende functies, zoals laborant, analist, productontwikkelaar en kwaliteitsmedewerker. Onze opdrachtgevers zijn actief binnen de levensmiddelenindustrie, farmacie, chemie en andere productiebedrijven. Ben jij een laborant of analist op (k)mlo-, hlo-, wo-, of PhD-niveau, óf heb je een levensmiddelenopleiding (mas, has of wo) afgerond, schrijf je dan in bij Balans en maak werk van je dromen.

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QC Technician Microbiology

Checkmark Labrecruitment

Tilburg, NB
30+ dagen geleden
Tilburg, NB
€2k - €3k Per maand
30+ dagen geleden
€2k - €3k Per maand
Waar ga je aan de slag - Where will you work

International company focused on advances in bioprocessing: high-value products and flexible solutions that address critical steps in the production of biologic drugs.

Wat ga je doen - What will your job be

As a QC Technician Microbiology you will be responsible for all in-process testing: FTIR analysis, bioburden, endotoxin

As a QC Technician Microbiology you will be responsible for all in-process testing: FTIR analysis, bioburden, endotoxin

  • You will perform final release testing of final product and documents results for product release, and assists with any additional related QC requirements
  • Bioburden and endotoxin analysis of samples including product and water
  • FTIR analysis of resins
  • Monitoring of controlled environments and records data for trend analysis
  • You will assist with OOS investigations, deviations and change controls associated with QC testing


Wat vragen wij - What are we looking for

For the position of QC Technician Microbiology we are looking for a driven Bachelor candidate with at least some years of relevant work experience in microbiology analyses

  • Experience in microbiological assays: environmental monitoring, water testing, bioburden, endotoxin
  • Ability to work independently once training has been completed
  • Familiarity with SAP and Canea preferred
  • High attention to detail applied to all aspects of daily activities
  • Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures
  • Dutch and English language skills are required


Wat hebben we te bieden - What do we offer

  • Long term position, which starts with a 12 months contract at the hiring company
  • Full-time position, where 32 hours a week is negotiable
  • Dayshift

Wil je meer weten - More information

For more information please contact Na Rae de Jong: 088 00 211 23
Vacancy: 6890

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Service Lab Pellicle and Reticle Competence Engineer

ASML

Veldhoven, NB
1 dag geleden
Veldhoven, NB
1 dag geleden
Service Lab Pellicle and Reticle Competence Engineer Research & development Mechanical engineering Chemistry & materials science Physics In a nutshell Location Veldhoven, Netherlands Team Research & development Experience 0-2 years Degree Bachelor Job Category Mechanical engineering, Chemistry & materials science, Physics Travel No Introduction Are you challenged by applications engineering in a dynamic high-tech environment with state of the art equipment? Would you like to contribute to successfully define, setup and build our new Pellicle Lab and ensure smoothly integration with the (existing) Reticle Lab? Then this position is worth reading. Job Mission The mission of the Service Lab Pellicle and Reticle Competence Engineer is to successfully define, setup and build the new Pellicle Lab and ensure smoothly integration with the Reticle Lab. Job Description Successfully define, setup and build the new Pellicle Lab and ensure smoothly integration with the Reticle Lab; Define and set clear design requirements (i.e. facility, equipment, tools, glues, contamination control, etc.) on manufacturability and serviceability and participating in early design reviews; Be a specialist working on the pellicle equipment; Work closely together with Development to ensure a smooth introduction of new Pellicles and related processes in the Service Lab; Create & maintain work instructions according to standards applicable; Create and give knowledge transfers; Troubleshoot Pellicle issues and participate in call out scheme; Create and maintain capacity forecasts and signal financial consequences of resources (tools, facilities and manpower) due to the introduction of new products or way of workings; Contribute to continuous improvement initiatives such as cycle time reduction, defect reduction, cost reductions all within the scope and related to Pellicles. Education At least a BSc. or MSc. technical degree in: Physics; Chemical; Optics; Mechanics. Experience Relevant working experience w.r.t. development applications and/or manufacturing processes in a high tech, low volume environment; Experience in the field of technical production engineering and quality methodology such as statistical process control and FMEA is an advantage; General Lithography experience in the field of wafer processing: photoresist processing, cleaning, metrology (CD, Overlay). Personal skills Broad technical knowledge, Strong analytical mind; Get-on and do it mentality, very active, plenty of initiative; Focused on quality, continuous improvement, good social and communication skills; Adequate English & Dutch language skills in speech and writing. Context of the position The sector TWINSCAN Factory is responsible for the production of Lithography systems, new and Refurbished. Within TF (TwinScan Factory) ShS (Shared Services) Service Lab Engineering, the department introduces new products and corresponding processes from development into (volume) and continuously adapts and optimizes the production and installation processes and provides support in connection with the organization.This vacancy is positioned within the group “TF ShS Service Lab Engineering” and it's main task is overseeing the quality of the Service Lab Engineering of Pellicles and Reticles for our TF & EF (EUV factory) factory. In the Service Lab we prepare wafers, pellicles and reticles for exposure. Furthermore, these are processed after exposure, measured and then recycled. The holder of this position reports to the Manager Service Lab. Other information Please add your recent CV and motivation / cover letter to your application for this position. We will not process your application without above mentioned documents.
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Electronic Hardware Designer (Mixed Signal)

Yacht

Best, NB
6 dagen geleden
Best, NB
6 dagen geleden
Bedrijfsomschrijving

Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals. Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: Philips Healthcare, Philips Innovation Services, Philips Research, ASML, TNO, DAF, VDL ETG, Océ and many others.

Functieomschrijving

Your challenge 

As an Electronic Hardware Designer you will be designing and developing the hardware for the control and acquisition subsystem for MR products for hospital and outpatient radiology facilities. You will work with a team of electrical hardware (RF, analog, mixed signal) and mechanical engineers, system engineering, manufacturing and service engineers to take products from concept through design into production using sound design approaches to meet the needs of our customers and their demanding environment.


You are a part of

You will be part of the R&D organization in the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare. The Business Unit MRI is a leading supplier for 1st line screening technology in Hospitals. MRI is one of the youngest and most innovative imaging technologies and is growing not only in applications but also in complexity of the system and acquisition techniques. It is the most suitable technology for soft tissue imaging due to its non-invasive nature. Imaging of neurologic and musculoskeletal structures is of key importance for our MRI products. The MRI R&D organization is responsible for hardware and software development including specification, integration, verification, validation and approbation of components from internal and external suppliers. The Data Acquisition System Hardware group develops and maintains MRI control and acquisition systems. The team consists of Analog & Digital Hardware Engineers.


You are responsible for 

In this role as Electronic Hardware Designer you will be responsible for the design (models, schematics and layout), realization, integration and verification of Analog and Digital Designs in the MR Acquisition Sub-System on the basis of design specifications in accordance with the functional specifications.


● Deliver high quality hardware design starting from requirements management till introduction in the factory (end to end). 

● Actively participate in design maintenance and solving end-of-life issues. 

● Document development efforts for the subsystem, component or module, including requirements, specifications, plans, reviews, test procedures, and test reports. 

● Coordinate, support and execute product tests to provide a traceable verification of the product.

Functie-eisen

To succeed in this role, you should have the following skills and experience:


● A Bachelor or Master in Electrical or Electronics Engineering 

● At least 5 years’ experience in Electronic Hardware development, preferably in a (safety) regulated industry such as medical devices, gas appliances, aviation equipment etc. 

Experience in the following: 

● Electronic product design throughout the full development cycle (prototype, pre-production, production).

● Electronic Design: Analog mixed signal / DC-DC converters / High speed digital / FPGA / DSP.

● Electronic Design Flow: Design for manufacturing / Design for reliability / Model driven design

● Experience in simulation of electronic designs (SPICE, MatLab, Advanced Design System, Microwave office) 

● Digital networking/connectivity: fiber optics, Ethernet, RS232, USB

● Interested in understanding and having an eye for the functionality of the full MR chain where the (to be) designed electronics are used.

● Strong communication skills, Team player.


Furthermore, you’re a disciplined team worker and are familiar working in multi-disciplinary multi-cultural teams. You have an accurate and quality minded attitude and are able to work independently with a pro-active personality.

Arbeidsvoorwaarden

Depending on your work experience and educational level, we offer you a gross salary of €3.300 – €5.200 per month, and you are eligible for the Yacht bonus scheme. Next to that, there is a possibility to get a company car with fuel card. Besides this, we offer a healthy work-life balance with flexible hours and possibility to work from home. We also offer other benefits, such as collective discount on health insurance and a good pension scheme.


We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!

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QC Inspector

Checkmark Labrecruitment

Tilburg, NB
30+ dagen geleden
Tilburg, NB
€2k - €3k Per maand
30+ dagen geleden
€2k - €3k Per maand
Waar ga je aan de slag - Where will you work

International company focused on advances in bioprocessing: high-value products and flexible solutions that address critical steps in the production of biologic drugs.

Wat ga je doen - What will your job be

As a QC Inspector, you will be responsible for providing Quality Incoming Inspection support to ensure delivery of the highest quality

As a QC Inspector, you will be responsible for providing Quality Incoming Inspection support to ensure delivery of the highest quality
The successful candidate will also be supporting FTIR analysis as part of the incoming inspection processes that will be implemented on the site.

  • Work on deployment of new or modified inspection solutions, up to and including, selection, design and implementation of fixtures, gauges, standards and methods.
  • Support quality teams from engineering knowledge to inspection processes.
  • Serve as a Subject Matter Expert (SME) for Geometric Dimensioning and Tolerancing (GD&T), Statistical Process Control (SPC), and ANSI ASQ Z1.4.
  • Perform FTIR Analysis of resins.
  • Initiate Quality document revisions including inspection plans, procedure changes.
  • Work with Manufacturing, Materials Management and Engineering and Quality in addressing nonconforming material investigations.
  • Support investigations for Complaints, Deviation and Corrective Actions.
  • Other responsibilities to be assigned as appropriate.


Wat vragen wij - What are we looking for

For the position of QC Inspector we are looking for an experienced bachelor candidate in Chemistry, Material Science or Engineering with 2-4 years of relevant work experience

  •     Knowledge of ISO 9001:2015 Quality System Regulations
  •     Familiarity with FTIR material analysis
  •     Strong communication and problem-solving skills required.
  •     Applied knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Statistical Process Control (SPC).
  •     Technical writing skills, including work instruction / procedure, testing protocol and summary report creation.
  •     Experience with hard gauging and hand tools for taking measurements.
  •     Familiar with medical devices, bioprocessing equipment, military or aerospace industry inspection practices and standards.

Wat hebben we te bieden - What do we offer

  • Long term position, which starts with a 12 months contract at the hiring company
  • Full-time position, where 32 hours a week is negotiable
  • Dayshift

Wil je meer weten - More information

For more information please contact Na Rae de Jong: 088 00 211 23
Vacancy: 6893

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Regulatory Affairs Manager, Europe

Endologix, Inc

‘s-Hertogenbosch
30+ dagen geleden
‘s-Hertogenbosch
30+ dagen geleden

The Manager, Regulatory Affairs EU is the designated Endologix Authorized Representative in the European Community. The Manager is responsible for various regulatory activities in Europe, working in collaboration with the Global RA team and local EU team. The Manager, Regulatory Affairs EU will be the person responsible for Regulatory Compliance in Europe, the ‘Responsible Person’ as described in the new EU Medical Device Regulation - Article 13, and is the Quality Management Representative for the European organization. This position reports directly into the Sr. Director of Regulatory Affairs and has a dotted reporting line into local EU leadership.


  • Act as the Person Responsible for Regulatory Compliance (PRRC) as part of the organization’s role as EC Authorized Representative for Endologix, LLC. for the AFX, Nellix and Ovation/Alto product platforms.
  • Act as the ‘Responsible Person’ as described in the new MDR - Article 13
  • Acts as the Quality Management Representative for the site.
  • Is responsible for compliance of the Quality Management System to the Endologix Quality Manual and external regulations.
  • Serve as Endologix representative to MedTech Europe and in professional meetings.
  • Manage Regulatory inspections.
  • Review technical file and design dossier applications and annual updates generated by Regulatory Affairs for submission to the European notified body and regulatory authorities in applicable EMEA countries and for all product platforms.
  • Manage regulatory interactions with partners in Europe and maintains complete files on certifications and approvals.
  • Prepare, submit, monitor, and track all local product registrations and certifications within Europe and communicate closely with RA teams worldwide.
  • Develop strategies and propose content for responses to Competent Authority requests for information. Obtain and document cross-functional review of proposed responses in collaboration with RA teams worldwide.
  • Provide monthly updates to the organization on new or revised guidelines, standards, directives, the EU Medical Device Regulation, best practices, and associated trends.
  • Represent EU regulatory affairs on designated project teams.
  • Develop, oversee and manage the Regulatory Affairs-EU procedures and processes.
  • Prepare reports and assesses metrics for periodic management reviews.
  • Control of the RA budget for Europe to meet established company objectives for financial performance.

Education:

  • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs

Experience:

  • At least 5 years’ experience in the medical device industry or regulated industry in a regulatory affairs or related function is required.
  • Working experience and knowledge of European Medical Device regulations, directives, guidances, notes, and relevant European and international standards (e.g., MDD 93/42/EEC, ISO13485, ISO14971, ISO25539-1, ISO14155, FDA QSR) is required. Must provide leadership, creativity, and business acumen when interpreting regulatory standards and guidance documents.
  • Experience dealing with regulatory authorities of multiple countries in Europe is required.
  • Excellent notions of English, and strong verbal and written communication skills required. Prior international communication experience required.
  • Strong interpersonal skills including ability to interact with high degree of diplomacy are required.
  • Knowledge of global medical device regulations and product development processes preferred.
  • Ability to work both independently and in a fast-paced, dynamic cross-functional team environment where drive is critical to success is required.
  • Understanding and expertise in Microsoft Office applications required.

Your application:

If you're interested and qualify for this position, please upload your motivation letter and resume through the Endologix Career Site. We have no explicit closing date however intend to fulfill this position shortly. If you are interested we urge you to apply as soon as possible. After a pre-selection process based on your CV, you will be invited for telephone and/or face to face interviews.

 

When you apply for a current opening, you may choose to provide us with certain categories of personal information like your name, contact information, nationality, and details over your employment experience, skills, affiliations, education and professional certifications. It is our legitimate interest to use this personal information to assess your candidacy for a position. CV's and other documentation provided to us may be shared with and reviewed by our staff at a local office and/or corporate headquarters in the United States using secure, cloud-based solutions. We keep your personal information only as it is warranted to fulfill our commitments to you, or to adhere to legal or regulatory requirements. For information on your privacy rights and how to contact our Data Protection Officer and European Representative, please click herefor our Privacy Statement.

 

 

Endologix does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on our career site.  

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Quality Control Scientist

Thermo Fisher Scientific Inc

Tilburg
3 dagen geleden
Tilburg
3 dagen geleden

Location & department
Within Patheon, part of Thermo Fisher Scientific in Tilburg, we are responsible for the development and production of commercial medicines in dosed forms (soft-gel capsules).
You can think of products such as paracetamol, ibuprofen, but also various supplements. The soft-gel capsules are available at pharmacies and drug stores but also on a doctor's prescription. Because everyone contributes to the development and production of our soft-gel capsules, we are all responsible to make the world healthier, cleaner and safer.
The Lab Services Section is part of the Quality Control Department and ensures customer projects delivering results on time. Specifically, the Lab Services Section supports QC with equipment qualification, troubleshooting, investigations, documentation, and operational activities. The Section is also responsible for the Stability program.

Position

The Quality Control Scientist has a broad analytical interest and profound knowledge of relevant analytical techniques (e.g. HPLC, GC, UV-Vis, IR, titration) and measuring methods. You are foremost a problem solver based on robust root cause analysis, pragmatically combining different types of information in a GMP environment. You like working in a fast-paced environment, where you keep you internal and external customers at all stages satisfied and up to date. You will be reporting to the QC Supervisor Lab Services.

What will you do

  • Support the QC Department specifically with troubleshooting and investigations.
  • Conduct or support with Out of Specification & Out of Trend investigations. Review failure reports for Out of Specification test results and write problem analysis and corrective action report (Deviation/CAPA).
  • Execute Root Cause Analysis in case of Out of Specification results.
  • Resolve and/or prevent technical or procedural issues and troubleshoot results and perform Root Cause Analysis.
  • Perform routine stability analyses.
  • Execute trend analyses and always be focused on continuous improvement.
  • Generate protocols, methods and reports.
  • Keep up to date with current regulatory requirements/guidelines on (ICH/FDA), GLP/GMP, pharmacopeia requirements (EP/USP) with respect to Quality Control and stability studies.
  • Align with other departments such as Operations and R&D.
  • Work proactively, be resourceful and independent and a good team player.

Requirements

  • Bachelor’s degree in Analytical Chemistry (or related) in combination with 3-5 years of experience in a pharma or food industry.
  • Broad analytical interest and profound knowledge of analytical chemistry and measuring methods.
  • Pragmatic problem solver in a GMP environment.
  • Knowledge of statistics and able to execute and interpret trending.
  • Knowledge of IQ OQ PQ DQ in pharma.
  • Excellent reporting capability and organizational skills.
  • Good communicating skills (in writing and verbal) in English at basic knowledge of Dutch.

About Us
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. 

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Ervaren Microbiologisch Analist

Oxford Global Resources

Oost Brabant, NB
11 dagen geleden
Oost Brabant, NB
€2.6k - €3k Per maand
11 dagen geleden
€2.6k - €3k Per maand

Heb jij werkervaring in de microbiologie en ben je op zoek naar dé plek om jouw carrière en jezelf verder te ontwikkelen bij een internationaal toonaangevend bedrijf?
Functieomschrijving
Voor een van onze opdrachtgevers zijn we op zoek naar een ervaren laborant die ervaring heeft microbiologische testen die zich graag wil ontwikkelen binnen de microbiologie. In deze positie ben je verantwoordelijk voor het opleiden en trainen van junior collega's, verder hou je je bezig met het signaleren en opvolgen van deviaties, CAPA's en verwerken van de resultaten van kwaliteits testen. Er wordt onder strakke GMP-richtlijnen gewerkt dus ervaring met kwaliteitsystemen is een vereiste.
Verantwoordelijkheden
  • Uitvoeren van kwaliteitscontroles zoals steriliteitstesten / bioburden / toxines
  • Trainen en opleiden van collega-laboranten en operators
  • Invoeren van testresultaten en data-analyse/trending maken en eventueel deze beoordelen
  • Opstellen en uitvoeren van deviaties
  • Registreren van afwijkingen en een bijdrage leveren in troubleshooting en/of oplossingen
  • Leveren van een bijdrage in verbeteringsprojecten

Profiel
  • Afgeronde MLO/HLO opleiding in de richting microbiologie of life sciences
  • Enkele jaren werkervaring in de microbiologie
  • Ervaring met elektronische data verwerking
  • Je bent resultaatgericht, kwaliteitsbewust, initiatiefrijk, flexibel en je hebt schakelvermogen
  • Je beschikt over goede communicatieve en sociale vaardigheden
  • Goede beheersing van de Nederlandse en Engelse taal

Arbeidsvoorwaarden
  • Dienstverband: Start via Oxford Global Resources (verlenging mogelijk)
  • Salarisindicatie: van €2600 tot €3000 Euro per maand
  • Werktijden: 40 uur per week
  • Regio: Oost-Brabant

Vacaturenummer: 16997
Imporatant note; Residence permit is required. Please do not apply if you do not have a residence permit to live and work in the Netherlands. Your application will not be processed

Oxford Global Resources is het grootste recruitmentbureau binnen de vakgebieden Science, Engineering en IT. Al onze recruiters hebben zelf een relevante achtergrond binnen deze gebieden en helpen je graag bij het vinden van de perfecte baan in ons uitgebreide netwerk.
Als gespecialiseerde partij hebben wij een groot aanbod aan laboratorium vacatures op het gebied van Quality Control (QC) en Research &Development (R&D) binnen diverse sectoren, waaronder de Farmaceutische industrie, Biotechnologie, Contract Manufacturing, Contract Research, Voedingsmiddelenindustrie, Chemie, Milieu en Plantensector.
Oxford is altijd op zoek naar talent met expertise op het gebied van Biotechnologie, Immunologie, Biochemie, Virologie, Microbiologie, Moleculaire Biologie, Life Science, Analytische Chemie, Fysische Chemie, Polymeerchemie, Petrochemie en Diagnostiek. Wij komen graag in contact met kandidaten die ervaring hebben met een of meerdere van de volgende technieken: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, viruskweek, celkweek, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, kloneren, sequencing, eiwit zuivering, purificatie, HPLC, UPLC, chromatografie, fysische chemie, viscositeit, smeltpunt, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titraties, Karl Fisher, formuleren, steriliteit, determinaties, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
Vind je deze vacature interessant? Of ben jij op zoek naar een functie op MLO, HLO, BSc, WO, MSc of PhD en heb je interesse in de vacature laboratorium Assistent, Laborant, Laborant monstervoorbereiding, Analist, Technician, Assistant Scientist, Associate Scientist, Scientist, Manufacturing Specialist, Process Engineer, Validatie Engineer, QA (Quality Assurance) Officer, RA (Regulatory Affairs) Officer, Supervisor, Teamleider, Afdelingshoofd, Hoofd Laboratorium, Manager, Director, etc. Neem dan direct contact met ons op!

Salaris

€3k - €6k Per maand

Type functie

Fulltime

Geplaatst op

21 dagen geleden

Beschrijving

Waar ga je aan de slag - Where will you work

International company focused on advances in bioprocessing: high-value products and flexible solutions that address critical steps in the production of biologic drugs.

Wat ga je doen - What will your job be

As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis. 
As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products

We are looking for two professionals in Quality: a Quality Manager and a Quality Assurance (QA) lead:

As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis. 

  • Manage the daily Quality activities of column products from incoming raw material release through batch record review and release of finished goods. Manager of the Quality team within the production site Breda.
  • Establish and maintain a QC microbiology laboratory by building a robust microbiological system through ISO cleanroom cleaning validations, RODI water monitoring, and environmental monitoring and trending
  • Lead/administer audits of systems, processes and products to ensure compliance with ISO 9001 and customer requirements and compliance to the Quality System
  • Design, compile, analyze, trends and issue QA and QC performance metrics reports. Present summaries to senior management team during e.g. Management Reviews
  • Manage and develop QA and QC staff members; plan and implement QA and QC resources to support quality related activities
  • Member of the of the local Management Team

As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products. As a QA lead you will report to the Quality Manager.

  • Manage the Quality Documentation System and archival process, maintain employee training.
  • Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews.
  • Work with subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances and complaints.
  • Assist with compliance audits (customer, supplier, internal, external).
  • Manages daily schedule and communicates with peers and management for completion of tasks associated with product release.
  • Gathering of KPIs for weekly and monthly senior management meetings.


Wat vragen wij - What are we looking for

For this position as a Quality Manager we are looking for a bachelor or master candidate in Life Sciences with at least 7 years of experience in Quality (eg ISO9001)   

  • You have at least 3-5 years of experience mentoring and supervising direct reports, this can be in a manager or team lead role
  • Experience leading Quality audits both internally and externally; lead auditor certificate preferred
  • Experience with LEAN implementation strongly preferred
  • Experience with SAP and EDMS
  • Enthusiastic, team player, collaborative across all departments to achieve the common goals
  • Affinity to work in a high paced start-up environment, which means being flexible, being able to deal with uncertainty and changes of direction and work and thrive in a highly dynamic environment.

For the QA lead we are looking for a bachelor/master candidate with a degree in Life Sciences

  • You have at least 5 years’ work experience within Quality Assurance in an ISO 9001 certified facility or equivalent.
  • Internal auditor certification is preferred.
  • Experience and knowledge of IT software platforms that support Quality Management Systems.



Wat hebben we te bieden - What do we offer

  • Both positions are long term positions, starting with a 12 months contract at the hiring company
  • Competitive remuneration package, including a yearly bonus, non-contributory pension and partial compensation on your personal health insurance
  • Full-time position
  • Dayshift

Wil je meer weten - More information

For more information please contact Na Rae de Jong: 088 00 211 23 or narae@checkmark.nl or Talel Lakhal: 088-0021127
Vacancy: 6902