Description
Quality Control expert - stability testingWe have a new opportunity for an experience laboratory experience to join a project which will focus on all GMP related QC activities for sterile products.
Daily tasks:
Analytical Change Control Management (QA Gate Approval, Change Phase Management)
Approval and Implementation of analytical TM (pharmaceutical dosage forms, excipients, packaging materials)
Approval of method validation (for cleaning validation)
Review/Approval of analytical change/transfer documents
Updating of SOPs/FRMs
Audit and inspection support
Ensure timely delivery of complete and consistent source data to DRA REG CMC
Coordinate and provide review of CMC documentation
Requirements: University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Advanced quality and regulatory understanding
Experience in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology is an advantage
Good Analytical chemical and/or biological expertise
Profound knowledge in cGMPs
Pharmaceutical software applications, e.g. TEDI, CCex
Languages: English fluent and German at least conversational
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.