QA Project Support

QA, Change control, Validation, Trackwise

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 Project Support.

Keywords
  • >5 years QA experience
  • Change control
  • Validation
  • Trackwise
  • Dutch and English

In addition to the base business activities for our commercial products, the company also has a large project portfolio to introduce new products, implement new technologies, improve on our processes, perform ELM and increase our capacity to be able to deliver future demands.
We are looking for someone to support these portfolio projects. In the projects you will typically be a core or extended team member with the responsibility to assure project changes are implemented according to cGMP guidelines and quality management systems.
You will act as a quality expert and apply their Quality Systems to create, review and approve GMP documentation. You work in close collaboration with other departments (Operations, QC, Engineering, RA, etc.)

The activities include:
  • Review and approve change controls, validation protocols and reports, validation assessments, URS, and applicable lifecycle documentation;
  • Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation;

Profile

The ideal candidate has a B.Sc. in e.g. bioscience, chemistry, pharmacy with at least 5 years of QA experience in pharmaceutical or related industry. You have up to date knowledge of current GMP regulations and good communication skills in both Dutch and English. Furthermore, you have experience with change control and all documenting related activities, validation and documentation systems like Trackwise.
Preferably, you also have experience with systems like Delta-V, Scada, PAI or MES, Computer System Validation (CSV) and/or experience with sterile manufacturing.

Benefits

Project for at least 1 year
Salary: >4000 gross/month
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. 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), such as rheumatoid arthritis and psoriasis. 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 A2300073)
Location Leiden
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QA Project Support

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