Senior Quality Assurance Officer

Geleen, Netherlands

Job Description

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.

The Senior QA (Quality Assurance) Officer is responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.

Key responsibilities:

  • Plan and execute quality assurance activities (document management, batch record and label issuance, batch record review, equipment and supplier qualifications) including documentation.
  • Monitor compliance with all applicable GMP and safety standards in the area of quality assurance.
  • Support the Qualified Person in his role, including audits and quality training.
  • Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.
  • Prepare data for trending (QRB, Annual Product Review) and support and attend internal and external audits.
  • Suggest process improvements and actively follow up improvement programs.
  • Involved in planning activities in cooperation with the Manager QA.
  • Provide guidance to QA Officers.
  • Backup for Manager
  • Suggesting training activities.

This position involves judgement of batch related documents, therefore the position requires a very precise and responsible working attitude.

Key requirements:

  • Higher vocational education or BSc in chemistry/biotechnology.
  • Significant experience with Quality.
  • Knowledge of GMP.
  • Good communication skills in English.
  • Accuracy, tidiness, self-organized, flexible, attention to detail, team player.

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: R19392