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QA Operations Manager (f/m/d)

companyLonza
location3930 Visp, Schweiz
VeröffentlichtVeröffentlicht: 13.8.2024
Vollzeit

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.

As QA Operations Manager for Drug Product Services (DPS) in Visp, you will represent Quality Assurance in cross-functional teams, including but not limited to Manufacturing, MSAT, QC, Engineering, Supply, Qualification/Validation and others to effectively execute tasks related to Drug Product processes.

Key responsibilities:

  • Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations

  • Ensure shop floor QA oversight (regular presence in the cleanroom)

  • Assess, review and approve GMP documents and quality records e.g. SOPs, risk assessments, deviations, investigation, CAPAs, change controls, complaints, APR/PQRs, protocols, executed MBRs

  • Act as QA representative during the conduction of internal / customer / regulatory inspections and audits

  • Provide GMP-related trainings to Operations personnel

  • Support continuous improvement programs to establish an effective Quality Management System for DPS Visp

  • Key requirements:

  • Master of Science in biotechnology or a related field

  • Significant work experience in the GMP regulated environment, in relation with aseptic manufacturing activities and preferably within a Quality Unit

  • Experience working with stakeholders from different departments and management levels

  • Fluent in English (written and spoken), German language 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.

    Reference: R60662