Process Expert Drug Product
Process Expert Drug Product
Lonza
Visp, Switzerland
Key responsibilities:
- Implements manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating batch data, resolving issues, troubleshooting manufacturing processes and making recommendations for resolution;
- Provides front line technical and procedural support, working with the manufacturing team, engineers and QA operations;
- Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements;
- Responsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area;
- Proactively driving optimization projects for manufacturing processes;
- Owns process related investigations and critical deviations and assists in decision making on production issues;
- Drives process changes, CAPAs, and CAPA effectiveness checks related to process within required timelines and through GMP systems (e.g. Trackwise, SAP, MES, training, etc.);
- Be a resource to other departments as Subject Matter Expert;
- Performs training activities of relevant areas;
- Drives innovation and improvement projects comprising general manufacturing aspects for the production plant.
Key requirements:
- Bachelor/Master Degree or relevant experience preferred;
- Preferred area of study: Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree;
- Min of 1 year of experience in Sterile Manufacturing on the shopfloor and/or QC/QA;
- Familiarity with GMP requirements, quality procedures and SOP execution;
- Good communication skills and interaction with a variety of interfaces within the organization and within the shopfloor;
- Structured, focused, proactive and well-organized working attitude;
- Focused on collaboration and motivation; guided by scientific principles;
- Prepared to work flexible working hours;
- Proficient in English, German is an advantage.
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