Senior QA Expert Qualification

Location: Stein, AG (Switzerland) Relocation assistance is available for eligible candidates and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of 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. Ready to make a difference? Apply today What you'll get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance Along with competitive salaries, you'll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on What you'll do: Act as responsible QA for establishment, execution and maintenance of Equipment and Infrastructure related qualification/validation activities in order to allow manufacturing of sterile medicinal products (Drug Products at existing or future aseptic Fill and finish production lines) Acts as contact person for GMP related issues (e.g. deviations) and their proper handling in shared global QMS systems such as Trackwise, Kneat Ensure proper qualification strategy for the equipment/infrastructure by adherence to the corresponding site VMP(s), Regulatory requirements as well as Global and local procedures during CAPEs and/or OPEX Projects Supervise activities like GMP status and trending of equipment, (re-) qualification/(re-) validation of Production equipment e.g. sterilization processes, 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 equipment/infrastructure qualification documents life cycle management e.g. approval of SOPs, qualification protocols and reports What we're looking for: Degree in life science (e.g. chemistry, biology, pharmacy) or equivalent experience Solid experience with aseptic fill&finish lines for drug product in a GMP environment is a must Solid experience with qualification and validation of production equipment (of fill&finish lines) Experience with health authorities Audit (e.g. Swissmedic, FDA) and Customer inspections is an advantage 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 Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.  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 disability, protected veteran status, or any other characteristic protected by law.