IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (IMPs) to our patients in compliance with cGMP. We serve as the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland, overseeing quality and compliance across all areas.
Our purpose is to foster a space for experimentation by coaching and celebrating learnings to build a purpose-driven quality community that delivers innovative medicines to patients.
This position within IMP Quality Operations Switzerland requires a high level of flexibility, the ability to work under pressure, and a strong sense of responsibility. Candidates should have detailed knowledge of GMPs, along with outstanding interpersonal and negotiating skills.
The role of the IMP QA Manager (IMP-QM):
* Acts as a delegate of the Swiss RP for IMPs
* Holds QA responsibility for GMP compliance in the manufacture, analysis, and release of IMP batches.
* Reviews and approves GMP procedures, records, reports, SOPs, master batch records, discrepancy and change records, and validation reports.
* Reviews and approves process design project plans and reports.
* Performs self-inspections in GMP plants and laboratories.
* Reports directly to the RP and RP deputy.
The role of the IMP Quality Single Point of Contact (IMP-QSPOC):
* Serves as a member of the technical development team (TDT) for early-stage IMPs.
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