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.
- 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
- 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
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 firstname.lastname@example.org