Senior QA Expert Compliance DPS, Audit Manager 80-100% (m/f/d)

Lonza AG

Basel; Stein
  • Publication date:

    23 January 2023
  • Workload:

    80 – 100%
  • Contract:

    Unlimited employment

Senior QA Expert Compliance DPS, Audit Manager 80-100% (m/f/d)

Switzerland, Basel
Switzerland, Stein

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.

For Drug Product Services (DPS), our successful DP focussed 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  Senior QA Expert Compliance DPS, Audit Manager.

Key responsibilities

  • Management of customer audits and health authority inspections including

  • preparation of documents and communication with customers prior to audit

  • participation in front office as host of auditors/inspectors

  • documentation of outcome in audit management system

  • support and follow up of CAPA plans to potential observationstogether with internal functions

  • Coordination audit/inspection related activities internally

  • Setting up an efficient system to track the status of audit/inspection responses and CAPA plan

  • Support and execution of GMP compliance activities e.g. status reporting and trending of changes, non-conformities, CAPAS, self-inspections, document management, local implementation of corporate document

  • Backing establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for QC and manufacturing plant

Key requirements:

  • Academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences or related field

  • Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing (e.g. QA oversight, QA operations) or analytical testing (QA for QC)

  • Excellent working knowledge in EU and US GMP regulations relevant for sterile manufacturingand analytical testing

  • Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. Document Management System) and processes for Drug Product manufacturing and analytical testing

  • Exceptional negotiation and communication skills as well as customer focus (intern/external)

  • Excellent knowledge of written and spoken English, basic knowledge of German

  • Open minded, self driven, independent

  • Structured working attitude

  • Likes to work in an international team and intercultural environment, team player

  • Agile to adopt to new situations and moving targets in short period of time

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: R50856


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