QA Cmo Expert Commercial Products

vor 2 Wochen

Lausanne, Schweiz Axepta SA Vollzeit

My client is a renowned growing international biopharmaceutical company with outstanding reputation in the industry.

Due to this growth, my client is looking for a QA CMO Expert for commercial products (small molecules to join their office based near Lausanne area.

The role will support the manufacturing process activities performed at CMOs in relation to commercial Drug Products.

**Responsibilities**:

- Support the day-to-day process activity oversight at CMOs to ensure timely delivery of process documentation for commercial Drug products.
- Coordinate resolution of process deviations, and support troubleshooting activities at CMOs in collaboration with internal QA & Supply and Pharmaceutical development departments
- Act as owner and / or technical process expert for Change Controls & Deviations
- Review and Approve Process documents: Risk assessment, Validation Master Plan and report, Master Batch Record, Drug Product
- Lead process validation post-initial launch for small molecules programs (Oral Solid Dosage Forms) for process transfer and/or process optimization.
- Maintain and update Drug Product process knowledge.
- Attend CMOs audits as process SME.

**Your profile**:

- Bachelor's or Master (preferable) degree in Pharmaceutical Process.
- Experience of min 5 years in Pharmaceutical industry with at least 3 years of experience at a manufacturing site.
- Strong knowledge of process validation regulations and CGMP for small molecules Drug Product.
- Various process expertise for Oral Solid Dosage Forms (Tablet) and Semi-Solid Dosage Forms (Cream) is an asset.
- Experience in dealing with contractors.
- English fluency written and spoken (the company language) and French is an asset.

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