Senior QA Expert Manufacturing Release 80-100%

Vor 5 Tagen

Stein AR, Schweiz Lonza Group Ltd. Vollzeit

Senior QA Expert Manufacturing Release 80-100% (m/f/d) page is loaded Senior QA Expert Manufacturing Release 80-100% (m/f/d) Apply locations CH - Stein time type Full time posted on Posted 20 Days Ago job requisition id R59178

Today, Lonza is a global leader in life sciences operating across three 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.

Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as a Senior QA Expert Manufacturing Release for supporting our new sterile Drug Product facility in Stein.

Key responsibilities:

  • Quality Oversight at DPS Manufacturing, including but not limited to, aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques
  • Author, review and approval of GMP documents (e.g. batch records, SOPs)
  • Review and approve protocols and reports e.g., APS, holding time studies, cleaning studies, equipment/room qualification as applicable
  • Review and approve change requests, deviations and CAPAs related to product and process
  • Facilitate the execution of deviation review boards
  • Provide support to Sterile Production Stein line functions in GMP compliance related issues in area of expertise
  • Lead or co-lead continuous improvement and innovation projects within quality operations
  • Lead or co-lead campaign preparation readiness and PPQ batches
  • Represent QA Operations in inspections, audits and local and global initiatives
  • Participate in self-inspections, GEMA walks and audits as required
  • Perform other duties as assigned
  • Deputy of Team Lead QA Operations-Growth Project as required

Key requirements:

  • University or academic degree (e.g. Masters) in Chemistry, Biology, Pharmacy or equivalent
  • At least 7-10 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products
  • Possess in-depth knowledge of Good Manufacturing Practice (GMP); sterile drug product aseptic manufacturing, Annex I regulations and ICH guidelines
  • Experience in Swissmedic inspections, FDA inspections, and other health authorities is desired
  • Possess strong project management skills, problem solving skills and ability to work autonomously
  • Customer-oriented mindset and collaboration with internal and external stakeholders
  • Ability to handle ambiguity and complexity of Growth Projects is a plus
  • Fluency in English (spoken and written) is a must. Fluency in German is 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.

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