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As a consultant, you will support the qualification and validation commissioning and qualification of labs equipments Key responsibilities : Act as the main point of contact for all quality compliance key topics regarding labs equipments Review and approve the URS and relevant documentation and support actively the risk assessment exercises (FMECA) Support the Commissioning & Qualification activities Support the creation of procedures, protocols and reports for qualification / validation Ensure qualification and validation of labs equipments Act within compliance and legal requirements as well as within company guidelines Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees Implementation and ensures adherence of appropriate regulations and quality standards, Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, Batch Production Documents (BPDs) or Manufacturing...

Define the technology transfer strategy Support the technology transfers and process validation  to the new biotech production site Support the implementations and performance of Quality operations (new process introduction, electronic batch records, change controls, quality events, periodic reviews, change-over management and others) Act within compliance and legal requirements as well as within company guidelines Work with the project team and the engineering companies on the detailed design deliverables concerning process equipment requirements and actively support the risk assessment exercises (FMECA) Review and approve process equipment related documentation (procedures, layouts, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations Support the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing...