Quality Associate

Company: XDES
Job type: Contract
XDES is specialist in recruitment van technisch ;

Job Description
Due to the increased demand due to the COVID vaccine program we are looking for a Jr. 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. Main 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 ;
  • Assist in the follow up of audit findings
Training general
  • Review completeness of training files of GCLP personnel.
  • Assign training curricula to GCLP personnel.
Equipment/Software validation
  • Write/review equipment validation protocols
  • Write/review software test protocols
  • Review validation documents

Job Requirements
  • Minimal BSc-level + 2 years of relevant experience
  • 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
  • Experience with performing immunological assays is a pre

Salary and Benefits
A great temporary job opportunity at an important healthcare company.

Contact Us
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer of via e-mail: Kenmerk: 9952.

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