jobid=A.0.0697
Our client is an innovative organisation in the biotechnology sector, focused on the development of advanced cell therapies. They specialise in treatments administered directly at the hospital, eliminating traditional logistical barriers in cancer care. Their approach aims to shorten treatment time and significantly improve patient accessibility. Job DescriptionAs a temporary Quality Equipment Specialist, you will be responsible for overseeing equipment quality within a high-tech production environment. You’ll ensure proper implementation, monitoring, and documentation throughout the entire equipment life cycle. This position requires close collaboration with various technical teams and a critical approach to process and documentation compliance with internal policies and regulatory standards. ResponsibilitiesReview and approve technical documentation related to equipmentEvaluate qualification protocols and reportsEnsure compliance with applicable industry standards (c GMP, FDA, ISO)Support calibration, maintenance, and decommissioning of systemsParticipate in risk assessments and follow up on deviations and corrective actionsProvide support during audits and inspections ProfileBachelor’s or Master’s degree in a technical or life sciences disciplineAt least three years of experience in pharmaceutical or medical manufacturing environmentsFamiliarity with regulations such as c GMP and ISO 13485Experience with equipment qualification and quality processesKnowledge of maintenance systems and quality tools (e.g., Veeva, Track Wise)Preferred: experience with CSV, automation systems, or Lean methodologiesAffinity with laboratory equipment is a plus Employment ConditionsRegion: South HollandSalary indication: €3,400 – €7,000 based on a 40-hour weekContract duration: 6 months, freelance or temporary contractWorking hours: full-time, hybrid work model possibleInternational work environment with opportunities for growth and meaningful impactVacaturenummer: 26017
