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Regulatory Compliance Specialist
vor 2 Monaten
About the Role
As a Quality Assurance Manager at Roche, you will play a critical role in ensuring the delivery of Investigational Medicinal Products (IMPs) to our patients in compliance with current Good Manufacturing Practices (cGMP). You will be responsible for providing quality and compliance oversight of all manufacturing units and clinical packaging in Pharmaceutical Technical Development in Switzerland.
Key Responsibilities
- Act as a delegate of the Swiss Regulatory Authority (RP) for IMPs, ensuring compliance with regulatory requirements.
- Have QA responsibility for GMP compliance of manufacture, analysis, and release of IMP batches.
- Review and approve GMP procedures, records, and reports, including SOPs, master batch records, discrepancy and change records, and validation reports.
- Review and approve process design project plans and reports.
- Perform self-inspections in GMP plants and laboratories.
- Report directly to the RP and RP deputy.
About the Team
You will be part of the IMP Quality Operations Switzerland team, which is responsible for delivering high-quality IMPs to our patients. Our team is committed to creating a space for experimentation, coaching, and celebrating learnings to build a purpose-driven quality community that delivers innovative medicines to patients.
Requirements
- Detailed knowledge of GMPs.
- Outstanding interpersonal and negotiating skills.
- Ability to work under pressure and demonstrate a high level of flexibility.
