QA project support

Location Leiden
Discipline: Biotechnology
Job type: Permanent/Temporary/Freelance
Contact name: Beata Wydurska

Contact email: b.wydurska@panda-int.com
Job ref: 16492
Published: about 2 months ago

For one of the biggest pharmaceutical company worldwide, we are looking for a QA project support. 

Responsibilities

The QA contractor acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Engineering, RA, etc.)

The activities include, but are not limited to:

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

Qualifications

  • BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
  • Some years of QA experience in pharmaceutical or related industry (nice to have)
  • Up to date knowledge of current GMP regulations (must have)
  • Experience in Change control and all documenting related activities (must have)
  • Experience with documentation systems like Trackwise, True Vault (nice to have)
  • Experience with Systems like Delta-V, Scada, PAI or MES (must have)
  • Experience in Computer system validation (Delta V, VMS) (nice to have)
  • System Validation experience (nice to have)
  • Good communicative and advisory skills in both Dutch and English (must have), both (verbal and written);
  • Able to work independently as well as in a team.
  • Soft skills: ownership, team player on project level
  • 40 hours per week , 32 min. per week

Location: Leiden

Start date: January 2022

Duration: 1 year + extension

INTERESTED? Reach out to Beata Wydurska for more information by contacting +31 (0)20 20 44 502 or B.Wydurska@panda-int.com