Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
The QA associate will be the linking pin in the investigations into quality issues and with that responsible for the improvement of the overall quality status.
- Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
-Raise serious quality, compliance and /or GMP incidents to Site or Global Management.
- Setup and coordinate Site and Global critical issue meetings.
- Act as quality specialist and participates in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.
- Perform level assessment, review and approval of (deviation related) change controls.
- Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements.
- Act as a QA-representative during non-office hours and is therefore reachable through telephone. The QA-Associate will only return on site in case of serious quality incidents for which an immediate on-site assessment is required.
- Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation, analytical technical transfer
- Act as member in Quality Risk Management and /or root cause investigation sessions.
- BSc in science related subject and /or business-related area with 6 years of experience.
- Msc in science related subject and/or business-related area with 4 years of experience.
- Familiarity with PE. LEAN tools concepts and methodologies.
For more information please contact Ece Karakurt at firstname.lastname@example.org or +31 (0) 20 658 98 01.