E2E Process-Expert/Clinical Supply

Responsibilities:

• Support of in-house manufacturing orders at batch level and support of manufacturing plants (compounding, aseptic filling, visual inspection) from the creation and approval of manufacturing instructions to batch production record review and approval
• Approval of recipe-related parts lists and MES manufacturing instructions
• Execution of batch troubleshooting in the role of the owner in deviation management in cooperation with the manufacturing plants
• Function as change owner for process changes in cooperation with process experts from the manufacturing units and the other support groups
• Authorship of process SOPs as well as high-level and conceptual SOPs in cooperation with the subject matter experts and the other support groups
• Assume the role of Subject Matter Expert (SME) in handling complaints
• Timing coordination of batch record review and batch release in cooperation with quality assurance, taking into account order-related timelines of our customers (Clinical Packaging, TDT, Clinical Planner)
• Maintenance of the cleanroom status of the D and C areas, as well as operational support of routine microbiological monitoring (i.e. batch-independent monitoring in the D and C zones) in cooperation with QC (processing of deviation reports, ensuring compliance with global regulations and best practices, etc.)

Requirements:

• Degree in life science or engineering (e.g. pharmacy, pharmaceutical engineering, biotechnology, biology or similar)
• At least 5 years of professional experience in the pharmaceutical, GMP regulated industry in the field of production of sterile dosage forms (vials/syringes), quality assurance, quality control, pharmaceutical development or as a process engineer
• Strong knowledge of aseptic/sterile manufacturing processes and the corresponding GMP-compliant documentation, especially batch documentation
• Experience in writing deviation reports, operating regulations or other GMP documents