Senior QA Specialist, Process Validation 80-100% (f/m/d)
On-siteVisp, Valais, Switzerland
Job Summary
Ensure APIs and intermediates remain in a validated state throughout their lifecycle per Lonza procedures and regulatory guidance. Prepare comprehensive Validation Master Plans detailing required studies, lead process validation teams, and communicate with customers. Develop validation protocols and reports for manufacturing-scale studies, assess changes and deviations for validation impact, and maintain a documented continued process verification plan. Focus on process validation compliance for small molecules, including validation activities at scale and Product Quality Reviews. Requires a Chemistry degree, significant small molecules manufacturing experience, and strong cGMP knowledge. Based in Visp, Switzerland with relocation assistance available.
Required Qualifications
- Academic degree in Chemistry or any related field
- Significant experience in the area of small molecules manufacturing
- Experience in a validation function
- Strong background in cGMP
- Broad knowledge of manufacturing processes in GMP environment
- Experience in interacting with all kind of interfaces within the organization
- Experience in interacting with regulatory agencies (Swissmedic, FDA etc.)
- Fluency in English language
Desired Qualifications
- Good German language skills
- Experience in preparing comprehensive process specific Validation Master Plans
- Experience in leading the process validation teams
- Experience in communication with customers
- Experience in preparation of the validation protocols and reports for the studies performed at manufacturing scale
- Experience in assessment of changes and deviations during manufacturing for their impact on validation
- Experience in preparation and maintenance of a documented continued process verification plan
- Experience in Product Quality Reviews (PQRs)
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