Quality Manager
vor 3 Wochen
The Position
IMP Quality Operations Switzerland is responsible delivering Investigational Medicinal Products (“IMPs”) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all.
Our purpose is to create a space for experimentation by coaching and celebrating learnings in order to build a purpose driven quality community that delivers innovative medicines to patients.
This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs as well as outstanding interpersonal and negotiating skills, you should apply for this job.
The role of the IMP QA Manager (IMP-QM):
Acts as a delegate of the Swiss RP for IMPs
Has the QA responsibility for GMP compliance of manufacture, analysis and release of IMP batches.
Reviews and approves GMP procedures, records and 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):
Is as a member of the technical development team (TDT) for early stage IMPs the first
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