Activities
Executes manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshooting manufacturing equipment, and making recommendations for resolution.
Provides front line technical and procedural support, working with the manufacturing team.
Secures that each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements.
Responsible for establishing timely and high-quality production documentation (preparation, execution, and review of batch records) or other relevant GMP documents for the assigned production area.
Supports process-related investigations and assists in decision-making on production issues.
Supports process changes and CAPAs related to processes within required timelines.
Performs training activities of relevant areas as an operator and supports others and new joiners.
Operates, sets up, and cleans production equipment and premises for the production of liquid and freeze-dried drug forms (e.g.: compounding, parts washing, autoclaving, filter integrity testing, visual inspection).
Qualifications and Skills Required
- 2-4 years of experience in a GMP environment on the shop floor (preferably in sterile manufacturing of Drug Product).
- Fluent in either English or German (preferably both).
- Familiarity with GMP requirements, quality procedures, and SOP execution.
- Strong team orientation.
- Good communication skills and interaction with a variety of interfaces within the organization.
- Structured, focused, and well-organized working attitude.
- High motivation and dynamic drive.
- IT knowledge and knowledge in SAP and MES is a benefit.
- Prepared to work flexible working hours.
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