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

Switzerland, Stein

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?

What You Will Get

An agile career and a dynamic work culture.

An inclusive and ethical workplace.

Compensation programs that recognize high performance.

Benefits in Stein: You Will Do

Act as responsible QA for establishment, execution and maintenance of infrastructure&clean utilities related qualification/validation activities in order to allow manufacturing of sterile medicinal products

Acts 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 as well as Global and Local procedures during CAPEX and/or OPEX Projects

Supervise activities like 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

Acts as contact person for qualification documents life cycle management e.g. approval of SOPs, qualification protocols and reports

What We Are Looking For

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 is a must

Experience with health authorities Audit (e.g. Swissmedic, 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

You value working in a team, supporting your colleagues and contributing to a positive work culture is a matter of course to you

Fluency in English is a must, German language skills are an advantage

Reference: R73826

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