You are involved in GCCP project support from PU perspective, ideal background would be biotech engineer...
Process Expert Projects CGT, 100% (temporary)
- Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Zurich Hazard Analysis)
- Ensure that all critical parameters are within written Instruction (i.e. Master Batch Record)
- Support steward for assessment of technical changes and process changes (task manager ACC/PCC)
- Acts as Change Phase Manager
- Review validation and qualification protocols and reports for technical correctness
- Support the execution of process validations and qualifications, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution
- Responsible for creating the master manufacturing documents of assigned products, as appropriate
- Be knowledgeable of process design by providing input during process transfer etc.
- in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- Desirable MSc. or equivalent experience
- Experience – Minimum 5-7 years of experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Fluent in English and site local language (German)
… please contact Mr. Renato Imboden by phone on 061 269 90 60