Quality Assurance Expert Compliance, Drug Product Services

Lonza AG (Basel, Schweiz) Vor 25 Tagen veröffentlicht

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have 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 Quality Assurance Expert Compliance.

Key responsibilities:

  • Support establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for Quality Control and manufacturing plant
  • Create monthly and yearly quality reports
  • Act as fist contact concerning document life cycle management and compliance issues for shared systems (e.g. DMS, TrackWise)
  • Ensure proper qualification of staff by supervising adherence to GMP trainings and supporting training coordinator
  • Assure proper qualification of supplier/material/services as well as record and follow up on supplier audit status and CAPAs (incl. linked material)
  • Track GMP status of service providers (e.g. calibration, maintenance, consultants) and equipment/instruments/computerized-systems
  • Support (supplier) quality agreement during establishment and tracking status of current agreements
  • Supervise and execute GMP compliance activities such as status reporting, non-conformities, etc.

Key requirements:

  • Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
  • Significant working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in analytics or production
  • Very good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
  • Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. TrackWise), training management
  • Excellent communication and decision making skills
  • Excellent ability to provide solutions for complex challenges
  • Ability to work independently in a team environment
  • Very good knowledge of written and spoken English and German

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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Quality Assurance Expert Compliance, Drug Product Services

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