Quality Assurance Expert Injectable Primary Packaging

Switzerland, Stein

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 Injectable Primary Packaging.

Key responsibilities:

  • Adhere to GMP in packaging materials life cycle from production to release

  • Review and approve methods, qualification/validation/transfer protocols and reports in the field of parenteral primary packaging materials testing (e.g. vials, rubber stoppers, prefilled syringes and auto-injectors

  • Evaluate and  approve packaging related SOPs as well as major deviations for packaging materials

  • Act as fist contact concerning compliance issues for packaging materials (e.g. vials, stoppers, caps) including approval of specifications in Document Management

  • Release/reject of analytical packaging Quality Control testing

  • Qualify & maintain equipment and instruments for packaging materials testing

  • Validate methods for packaging materials testing

  • Supervise and execute GMP compliance activities like changes, non-conformities, self-inspections, data & document management

  • Participate in audits and inspections

  • Counsel and support all groups in projects and GMP aspects with regard to packaging materials

Key requirements:

  • Academic degree (Master or higher) in Pharmaceutical Sciences, Biochemistry, Chemistry or related field

  • Substantial work experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment in Production and Quality Control

  • Profound knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems

  • Excellent knowledge in development, testing and manufacturing of chemical and biological drug products

  • Excellent communication, project management and decision making skills

  • Proficient in providing solutions for complex challenges

  • Ability to work independently in a team environment

  • Fluency in English and German

  • Experience in aseptic production environment and large molecules preferred

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: R26236