Quality Associate Documentation

Location Leiden
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Ralph Looijen

Contact email: r.looijen@panda-int.com
Job ref: 11502
Published: about 1 month ago

A leading biotech company has an opening for a GCLP Quality associate/Documentalist for their Clinical Immunology Department in Leiden. We are looking for someone with a background in QA in biotech or pharma.

Due to the increased demand due to the COVID vaccine program we are looking for a GCLP Quality associate/Documentalist within the Clinical Immunology department. CI is responsible for coordinating and performing clinical sample analysis in support of our clinical vaccine trials.

Responsibilities

  • SOPs Documentation
    • Ensure correct approval of all GCLP relevant SOP’s.
    • Perform quality review and approval of all documents created in the document management system, review for alignment with other GCLP procedures, layout, template, revision history and other quality related details.
  • Deviation, CAPA:
    • Coordinate the deviations for the GCLP facility: ensure the timely reporting and closure, assist GCLP personnel in writing deviations, track status and alert when due dates are approaching, review all deviations and give feedback on content.
    • Assist in the follow up of audit findings
  • Training general
    • Review completeness of training files of GCLP personnel.
    • Assign training curricula to GCLP personnel.
  • Equivalent/Software validation
    • Write/review equipment validation protocols
    • Write/review software test protocols
    • Review validation documents

Profile

  • Experience working with quality systems (GxP)
  • Experience in interactions with QA
  • Ability to write, edit and review quality related documents
  • Experience with equipment and/or software validation
  • Good command of English in speaking and writing
  • Minimal BSc-level + 2 years of relevant experience
  • Experience with performing immunological assays is a plus

Project start date

01/02/2021

 

Project duration

9 months

 

Interested?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
 

For further information, please contact Ralph Looijen at +31 (0)20 20 44 502 or by email at r.looijen@panda-int.com