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IMP Quality Operations Switzerland is responsible for 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 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 to perform the below tasks:
Acts as a delegate of the Swiss Responsible Person (RP) for IMPs and is directly reporting to the RP deputy.
QA responsibility and oversight for GMP compliance in the manufacture and analysis of parenteral IMP batches.
Reviews and approves GMP procedures, records and reports (e.g. 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.
Who you are
You are an outstanding interpersonal with strong negotiating skills and bring the below qualifications and experience:
Bachelor or Master degree in Life Sciences or equivalent
10 years or more of relevant experience in the pharmaceutical industry.
Demonstrated experience in a Pharmaceutical Technical Development environment
Extensive understanding of technical development, FDA, EMA, ICH guidelines, and cGMP requirements.
Detailed knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1).
Excellent communication skills, both verbally and in writing in German and English.
Do you find yourself in this description, then this your role - please apply now, we are looking forward to your application.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.