Support the Bio-/ Chemical Quality Control (BCQC) department unit within the site including site project timelines
Participate in the transfer, development and validation of analytical methods including qualification of equipment needed for analysis
Actively contribute to the GMP Inspection Readiness of QC to ensure the fully compliance of relevant quality system and procedural documents
Actively contribute to the QC operational readiness managing projects (external and internal) and the assigned resources (including coordination and planning of people daily tasks) with regards to the controlled substances (as per ref. to Betäubungsmittelgesetz, BetmG 812.121)
Approve Purchase Order Requests and authorize the consumption for testing purposes limited to the actual required quantities on behalf of the Responsible Person
Act on behalf of the Responsible Person for controlled substances (as per ref. to Betäubungsmittelgesetz, BetmG 812.121)
Profile
Master or higher degree in biochemical / chemical/ pharmaceutical/ molecular sciences or similar
Profound experience in GMP regulated industry and lab experience
Proven experience and knowledge of (bio) chemical QC methods, method validation and analytical issue management
Proven experience in projects/ tasks coordination and profound experience in chemical or biochemical laboratories including experience in a regulated GMP environment