Switzerland Job Openings
Lonza
QA Expert Manufacturing Release 80 - 100% (m/f/d)
Stein
September 9, 2024
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 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
- Provide support to Sterile Production Stein line functions in GMP compliance related issues in area of expertise
- 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
- University or academic degree (e.g. Masters) in Chemistry, Biology, Pharmacy or equivalent
- At least 5-7 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 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
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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