Deviation & Capa Manager (m/f/d) - 80-100%
Vor 7 Tagen
Today, Lonza is a global leader in life sciences operating across three continents. While 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. As a Deviation & CAPA Manager, you will be responsible for managing deviations and CAPA (Corrective and Preventive Actions) processes within the logistics and hygiene areas of our MC1 and MC2 production sites. You will ensure full compliance with Good Manufacturing Practice (GMP) requirements and support continuous improvement initiatives across logistics, industrial hygiene, and related quality systems. Key Responsibilities Manage and evaluate deviations in logistics and hygiene areas for MC1 and MC2 Prepare, review, and maintain relevant GMP documentation (e.g., Deviation Reports, CAPAs, SOPs, Risk Assessments) Develop, review, and implement process-related procedures (e.g., Standard Operating Procedures, reports, risk analyses) Prepare, update, and monitor cleaning plans in logistics and hygiene-related areas Manage interfaces between Logistics, Clean Utilities, Industrial Hygiene, QA, QC Monitoring, Facilities, and Production Ensure all GMP-related technical requirements are correctly implemented, documented, and approved Support the preparation and review of GMP documentation and Change Requests (CRs) for MC1 and MC2 Provide expert advice for cross-functional investigations related to logistics and hygiene processes Conduct regular on-site inspections (Gemba Walks) to identify potential risks and improvement opportunities Execute CAPA actions and ensure timely follow-up and closure within the Quality Management System (QMS) Collaborate with cross-functional teams to address and resolve quality issues Identify trends and propose recommendations for process optimization and quality enhancement Support internal and external audits and regulatory inspections Qualifications Bachelor’s or Master’s degree in Logistics Engineering, Engineering, Material Management, Hygiene, or a related field Minimum of 5 years of experience in a GMP-regulated biopharmaceutical or manufacturing environment Strong knowledge of deviation management and CAPA processes Experience with Quality Management Systems (e.g., TrackWise, LIMS, etc.) preferred High level of technical understanding and the ability to interpret complex processes and systems Ability to work independently and manage responsibilities with minimal reliance on subject matter experts Strong analytical and problem-solving skills Language skills: fluent in German or English; bilingual proficiency is a plus 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. #J-18808-Ljbffr
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GMP Deviation
vor 3 Wochen
Zermatt, Schweiz Lonza VollzeitA leading life sciences company in Zermatt is seeking a Deviation & CAPA Manager to ensure compliance with Good Manufacturing Practice (GMP) and manage deviations and CAPA processes in logistics. The ideal candidate will have over 5 years of experience in a GMP-regulated environment, strong knowledge of quality systems, and proficiency in German or English....
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