In this position you support the supervisor in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions. Your responsibilities include: - Perform review of GMP relevant documents for compliance with SOPs across several customer groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.) - Perform review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, GLIMS specifications) - Negotiate deficiencies in GMP documents with the line unit
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
Global Pharma Company.
If you are interested then kindly send your resume to: firstname.lastname@example.org
- At least 5 years of experience in a corresponding line unit function (e.g. laboratory, manufacture, packaging, IT) - Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status - Sound scientific, technical and regulatory knowledge in a specific area - Detailed knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines - Good knowledge of drug development
Basic degree in laboratory, manufacturing or relevant discipline (e.g. apprenticeship, Bachelor)
Englisch : Very good