Senior QA Expert Compliance - Quality Systems and Tracking

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 Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland we have an exciting opportunity. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and be responsible to provide quality system oversight to units dealing with  activities by applying for the position as Senior QA Expert Compliance, Quality Systems and Tracking.

Key responsibilities:

  • Supervise and execute GMP compliance activities such as status reporting and trending of changes, non-conformances, CAPAS, audits/inspections, self-inspections, document management, supplier change notification, local implementation of company documents.

  • Establish and maintain quality management system at Drug Product Services (DPS) for quality control and manufacturing facility.

  • Preparation of monthly and annual quality reports

  • Act as primary point of contact for document lifecycle management

  • Support local quality risk management and risk register process

  • Assist in the evaluation and implementation of corporate guidance documents at the local level

  • Ensure the proper qualification of DPS staff by supervising adherence to GMP trainings

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

  • Good working knowledge in EU and US GMP regulations relevant for pharmaceutical compliance systems, audit/inspections

  • Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. TrackWise, Document Management System), training management

  • Excellent ability to provide solutions for complex challenges

  • Excellent knowledge of written and spoken English, German 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.

Reference: R45865