Senior QA Expert – Qualification & Validation – aseptic fill & finish lines (f/m/d) 80-100% at Lonza.
Location
Stein, AG (Switzerland). Relocation assistance is available for eligible candidates and their families.
Job Summary
Join our growing Drug Product Services team and help shape the future of pharmaceutical manufacturing! In this role, you’ll take the lead on qualification and validation activities for state‑of‑the‑art equipment and infrastructure supporting aseptic fill & finish lines. You’ll contribute to high‑impact CAPEX and OPEX projects while ensuring operational readiness in a cutting‑edge environment. As part of an international and supportive team, you’ll also have the opportunity to explore topics like data integrity or cleaning validation.
What You’ll Get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Competitive salaries and a wide range of lifestyle, family and leisure benefits.
What You’ll Do
Act as responsible QA for establishment, execution and maintenance of equipment and infrastructure related qualification/validation activities to support manufacturing of sterile medicinal products.
Act as contact person for GMP related issues (e.g. deviations) and their correct handling in shared global QMS systems such as Trackwise, Kneat.
Ensure proper qualification strategy for the equipment/infrastructure by adherence to site VMP(s), regulatory requirements and local procedures during CAPEs and/or OPEX projects.
Supervise activities such as GMP status and trending of equipment, (re)-qualification/(re)-validation of production equipment (e.g. sterilization processes) and adherence to global and local procedures for changes control, deviations and CAPA handling.
Act as SME for qualification related topics during audits and inspections.
Contact person for equipment/infrastructure qualification documents life‑cycle management (approval of SOPs, qualification protocols and reports).
What We’re Looking For
Degree in life science (chemistry, biology, pharmacy) or equivalent experience.
Solid experience with aseptic fill & finish lines for drug product in a GMP environment.
Solid experience with qualification and validation of production equipment (of fill & finish lines).
Experience with health authorities audits (e.g. Swissmedic, FDA) and customer inspections.
Teamplayer who values a positive work culture.
Fluency in English is a must; German language skills are an advantage.
Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment. Any success we achieve is only fair if it is achieved ethically.
Lonza is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.
Reference: R70948
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