Senior QA Expert, Manufacturing

About the role

Join a project‑phase team in Stein, Switzerland, driving operational readiness from a Quality perspective. You will ensure robust documentation, SOP compliance, aseptic process preparedness, and effective oversight of deviations and CAPA activities, influencing future manufacturing operations.

Key responsibilities

• Provide QA oversight for shop‑floor manufacturing activities, ensuring GMP compliance and operational readiness.
• Review and approve SOPs, work instructions, and other GMP documentation to support start‑up and sustainable operations.
• Partner with manufacturing teams to drive aseptic process readiness, including training and execution for APS and media‑fill activities.
• Lead quality events by reviewing and approving deviations, CAPAs, investigations, and related records.
• Act as the Quality representative during project discussions, audits, and inspections, communicating quality oversight strategy.

Required profile

• Proven experience in a GMP‑regulated pharmaceutical environment, preferably in sterile or drug‑product manufacturing.
• Strong background in quality oversight, deviation, CAPA, and investigation management.
• Fluent German and English communication skills.
• Willingness to work extensively on the shop‑floor, including full aseptic gowning.
• Degree (BSc, MSc or PhD) in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology or related field.

Required skills

• GMP compliance
• SOP development and review
• CAPA management
• Aseptic processing
• Deviation handling

What we offer

• Agile career and dynamic work culture.
• Inclusive and ethical workplace.
• Competitive salary with performance‑based compensation.
• Extensive lifestyle, family, and leisure benefits.