QA Officer

BSc., Quality Assurance, GMP, Change controls, Batch record review

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a QA Officer.

Keywords
  • BSc. / HBO
  • Quality Assurance
  • GMP
  • Change controls
  • Batch record review

In this role as QA officer you will support the base business and where applicable support the projects going on, with the responsibility to assure (project) changes are implemented according to cGMP guidelines and quality management systems.
You act as a quality expert and apply the Quality Systems to create, review and approve GMP documentation. You will work in close collaboration with other departments (Operations, QC, Planning, R&D etc.).
Responsibilities:
  • Paper and electronic batch record review;
  • Raw material release;
  • Document revisions review and approval;
  • Review and approve analytical method transfer protocols and reports;
  • Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation;
  • Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation;
  • Depending on experience supporting master material changes.

Profile

To fulfill this position, we are looking for BSc. / HBO candidates with a background in bioscience, chemistry, pharmacy or equivalent. You have at least one year of QA experience in the pharmaceutical industry. You are up to date with the current GMP regulations.
Other requirements:
  • Experience in Change control and all documenting related activities;
  • Experience with documentation systems like Trackwise, True Vault is preferable;
  • Good communicative and advisory skills in English, both (verbal and written), understanding of Dutch;
  • Able to work independently as well as in a team.

Benefits

Project for 6 months
32-40 hours
Hybrid role
Days of leave: 38
See here our other employment terms for this vacancy

Company profile

Johnson & Johnson Innovative Medicine is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicine. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), Janssen Biologics is part of the Johnson & Johnson family of companies

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2400026)
Location Leiden
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QA Officer

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