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Quality Assurance Process Validation Manager – 5017 LBD
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Quality Assurance Process Validation Manager for a 6-month contract (extension planned) based in the Visp, Switzerland.
The QA will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).
- Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to client’s procedures, and in compliance with regulatory guidance
- Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
- Leading the process validation teams including communication with customers
- Support R&D teams during the process design phase
- Preparation of the validation protocols and reports for the studies performed at manufacturing scale
- Assessment of changes and deviations during manufacturing for their impact on validation
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Master’s degree in chemistry or Biotechnology (PhD preferred)
- Proficiency in writing scientific reports in English
- Experience in GMP manufacture preferred
- Fluency in English
- Excellent communication skills
- Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
- Managing internal and external customer relations professionally and effectively