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QA Expert
Sterile Manufacturing & Fill Finish

We are looking for a proactive and quality-driven QA Expert to support sterile manufacturing and Fill Finish activities within a GMP-regulated pharmaceutical environment.

You will act as a key quality partner for aseptic operations, ensuring compliance, operational excellence, and continuous improvement across manufacturing, validation, and quality systems.

• Ensure ongoing compliance and enhancement of the GMP Quality System for Fill Finish and aseptic manufacturing
• Provide quality oversight and support batch disposition through review of manufacturing documentation, batch records, and deviations
• Review, approve, and maintain GMP documentation including SOPs, validation protocols, and technical reports
• Act as Subject Matter Expert (SME) for validation and qualification of sterile manufacturing processes and equipment
• Lead investigations for deviations, CAPAs, OOS events, complaints, and quality risks
• Drive change control activities impacting manufacturing processes, equipment, utilities, and quality systems
• Oversee aseptic operations including media fills, contamination control strategy (CCS), and environmental monitoring
• Support lifecycle management and validation of Fill Finish equipment: filling lines, isolators, autoclaves, lyophilizers
• Collaborate with CMOs and external manufacturing partners on GMP compliance
• Contribute to APQR/PQR, regulatory submissions, and inspection preparation
• Support health authority inspections and customer audits as a quality SME

• Master's degree in Pharmacy, Biotechnology, Engineering, Life Sciences, or a related discipline
• Minimum 3 years of experience in a GMP-regulated pharma or biotech environment
• Strong expertise in sterile manufacturing, aseptic processing, and Fill Finish operations
• Solid understanding of equipment qualification and validation (URS, FAT/SAT, IQ/OQ/PQ)
• Experience managing quality investigations, risk assessments, and change controls
• Hands-on experience in cleanrooms, isolators, and contamination control environments
• Strong knowledge of cGMP regulations including EU GMP and FDA requirements
• Fluent in English and German (mandatory)

• Compensation above market rate
• Missions matched to your expertise and profile
• Direct relationship with the team - no commercial middlemen
• Exposure to high-complexity sterile manufacturing environments

Send your CV to t@morganu.ch — we will come back to you within 48 hours.

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