QA Operations Specialist

City: Stein
Duration: 7 Months
Country: Switzerland

Job Purpose
Performs QA oversight of production and testing activities (shop-floor presence), ensuring compliance with cGxP, incl. Data Integrity and eCompliance, eg. as PU QA SPOC. Acts as reviewer/approver of production ( Assembly and Packaging) , records. Provides specialist support in the evaluation and execution of investigations and changes.

Major accountabilities:
• Review and approval of production, records ( Assembly and Packaging)
• Master Batch Record review and visual control of finished packed samples
• Provide shop-floor QA support and oversight of production and testing activities,
ensures compliance with cGxP, incl. data integrity and eCompliance
• Performs routine documentation activities
• Support exception investigations for non-critical deviations
• Supports change control activities relating to non-complex changes
• Support OpEx improvement projects

Must have
• Strong knowledge of GMP
• Several years of experience in pharmaceutical quality control, quality assurance or
• MS Office applications and other standard IT applications supporting Quality
• Good collaboration skills

Nice to have
• Experience in MES and SAP
• Experience in Assembly and packaging
• Experience in product release process or review processes

Education Qualification
• University degree with a scientific / technological background (e.g. Chemistry,
Pharmacy, Biology, Biochemistry, or equivalent)
• Qualified Person (depending on local requirements)

Good (oral and written) in English; fluent in local language (oral and written)