(Senior) Quality Control Expert
Currently collaborating with a leading Biopharma CMO in the Netherlands to find a (Senior) Quality Control Expert who will act as an Analytical Method expert during internal and external audits/inspections. Initial contract 1 year.
- Participates in the initial assessment of new methods to be transferred to QC
SME for method specific devices (initiation or review of URS, PQ and define maintenance requirements).
- Responsible for method validation plan including protocol, data review, statistical analysis, report preparation and review.
- Lead and participate platform method validation strategy implementation and assessment for future projects.
- Understand the method validation and implementation activities linked to the applicable expertise, gap analysis, method readiness and other QC related issues in his/her branch.
- Generate, review and approve QC documents and acts as expert for QC during internal and external audits and inspections.
- Implements and executes activities in the QC ensuring compliance with all existing GMP and safety standards.
- Masters or higher in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Chemistry.
- Preferred 10 + Years in Biologics QC/Analytical Development (MIN 5 years).
- Hands-on experience of analytical methods of physico-chemical methods, equipment and good practices for Biological Products.
- Good understanding of QC analysis e.g. HPLC, Capillary Electrophoresis, RTPCR, UV Spectrophotometer, Gas chromatography, ELISA, safety tests
- Person needs to be hands on in the lab. No lead function (real expert) meaning person should be able to develop, test and report the methods performed. Data driven.
- Desirable: Knowledge about ICH guidelines and other regulatory agencies. Global Audit experience.
- Duration: 12-month project (chance of extension)
- Start date: July
- Location: Maastricht area, NL
- Set-up: on-site
- Language: English
If you are interested in the above description, please apply with your CV today. Interview and offer can happen this or next week. For more information, please contact Merel van Os on +31 (0)20 20 44 502 or by e-mail at email@example.com