Found Description
Product Quality Expert
Takeda is looking for a Product Quality Expert to manage regulatory compliance for a biological product manufactured at our Neuchâtel facility in Switzerland. You will serve as a subject‑matter expert, supporting other products when needed, and ensuring adherence to FDA, EMA, ICH, and other regulatory standards.
Responsibilities
- Prepare annual Product Quality Reviews (PQR) in accordance with health authority requirements.
- Review and implement updated global release specifications for the Neuchâtel facility.
- Participate in GMP tours and inspections, ensuring the facility is inspection‑ready.
- Prepare and manage documentation for regulatory submissions, major change projects, and change controls.
- Review audit observations and regulatory agency questions, writing responses and coordinating with SMEs.
- Support the preparation of inspection and pre‑required documents.
- Par...