Senior QA Expert - Clean Utilities & Facilities; m​/f​/d

Senior QA Expert – Clean Utilities & Facilities (m/f/d) 80-100%

The actual location of this job is in Stein, AG, Switzerland
. Relocation assistance is available for eligible candidates and their families, if needed.

Join our growing Drug Product Services team and help shape the future of pharmaceutical manufacturing! In this role, you’ll take the lead and oversight on qualification and validation activities for state‑of‑the‑art infrastructure and utilities (i.e. clean water (WFI and Purified water), clean steam, compressed gases (air and nitrogen), clean rooms (from CNC to class

A), and HVAC) supporting our aseptic fill & finish lines. You’ll contribute to high‑impact CAPEX and OPEX projects while ensuring inspection and operational readiness in a cutting‑edge environment. Are you looking for a chance to be part of an international and supportive team? Apply today!

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• In addition to a competitive salary, numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.

• Act as responsible QA for establishment, execution and maintenance of infrastructure & clean utilities related qualification/validation activities to allow manufacturing of sterile medicinal products.
• Act as contact person for GMP related issues (deviations) and their proper handling in shared global QMS systems (e.g. Trackwise, Kneat).
• Ensure proper qualification strategy for infrastructure/ clean utilities by adherence to the corresponding site VMP(s), regulatory requirements and global and local procedures during CAPEX and/or OPEX projects.
• Supervise activities such as GMP status and trending of (re‑)qualification/(re‑)validation, adherence to global and local procedures for changes control management, deviations and CAPAs handling.
• Act as SME for qualification related topics during audits and inspections.
• Act as contact person for qualification documents life cycle management, e.g. approval of SOPs, qualification protocols and reports.

• Solid experience in qualification and validation of clean utilities & facilities (i.e. clean water (WFI and Purified water), clean steam, compressed gases (air and nitrogen), clean rooms (from CNC to grade
  
  A) and HVAC) for aseptic drug product manufacturing in a GMP environment.
• Experience with health authorities audit (e.g. Swiss medic, FDA) and customer inspections.
• Knowledge of regulatory guidelines GMP Annex 1, 11, 15.
• Degree in life science (e.g. chemistry, biology, pharmacy) or equivalent experience.
• Team orientation, strong support for colleagues, and a positive work culture mindset.
• Fluency in English is a must;
  German language skills are an advantage.