Description
CSV Laboratory Specialist - German SpeakingLocation: Southern Germany
Global pharmaceutical CMO client currently has a contract requirement for an experienced CSV Engineer for a contract role based in Germany.
The client has been undergoing large laboratory systems transformation and they require some support with the various projects they are undertaking.
Responsibilities:
• To support a variety of projects design to move towards a lean laboratory:
o Data handling review
o The capture of and use of ‘big data’ in the laboratory setting.
o Drive towards a paperless laboratory
o Drive to automated laboratory
• Review QA documentation, specifications and URS
• Review and approve protocols for IQ/OQ/PQ
• Bring expertise and coaching to the team
Experience Required
• Must be German speaking/reading/writing - the documents are written in the German language
• Experience of QA and Validation documentation writing /review essential
• Knowledge of regulatory requirements (GLP, GMP, FDA).
• Strong experience in a pharmaceutical environment - experience with aseptic environment a distinct bonus.
• Good communication and organisational skills.