QC Analyst Stability & Investigations

The analyst is responsible to perform stability routine testing studies, but should also be able to perform method verification & equivalence studies to meet updated regulatory and pharmacopeial policies. Furthermore, the analyst will be involved in review assessments of pharmacopeail and dossier updates.

Key activities

Perform analytical Stability testing
(Re)-validation, verification and/or remediation of analytical methods
Writing of protocols &reports
Maintain adherence to corporate policies and appropriate regulations through actions and decisions
Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions
First-line Troubleshooting of laboratory equipment
Active participation in changes or act as change owner as part of continuous improvement.

Your Profile

Bachelor degree in analytical chemistry/pharmacy or equivalent experience
Knowledge and familiarity with the use of Pharmacopoeia methods
A strong analytical oriented mindset.
Experience with working in a pharmaceutical environment
Experience with (re)validation or verification of analytical methods
Good knowledge of Pharmaceutical quality systems and production processes
Team player
Strong can-do mentality