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Qualified Person / Specialist Quality Assurance

Qualified Person / Specialist Quality Assurance

LocationBilthoven, Netherlands
Business SectorBiotechnology
Contact nameGuus Paulusse
Contact email
Job ref22091
Publishedabout 1 month ago
This Biopharmaceutical organisation works on the development and production of vaccines that are valuable for global healthcare. As an established Contract Development & Manufacturing Organization (CDMO) with over 50+ years of experience, they offer a wide range of expertise to independently develop and manufacture innovative vaccines for partners around the world, including (inter)national governments, public health organizations, biotech and pharmaceutical companies.

Start Date: ASAP / Duration: 1 year contract - Permanent / Hours: 40 hours per week (40% working from home is possible)

  • Assume responsibility as the QP in accordance with GMP regulations (50%)
  • Assume responsibility as Quality Assurance Specialist with GMP regulations (50%)
  • Hands- On support in setting up quality procedures, maintaining the electronic QMS and DMS system
  • Hands- On support in Documentation, Deviations, CAPAs and Change Controls are carefully reviewed and approved by you
  • Ensure compliance with regulatory authorities and maintain GMP standards
  • Collaborate with cross-functional teams to safeguard and drive continuous improvement in product quality
  • Investigate and manage deviations, CAPAs, and change controls as necessary
  • Support internal and external audits as a subject matter expert in GMP

  • Qualified Person (QP) certification is a pré in accordance with EU GMP regulations
  • WO education in a related scientific field
  • 10+ years’ working in a GMP-regulated environment, ideally within the biopharmaceutical industry
  • Thorough knowledge of relevant regulations and guidelines
  • You do have the competencies: Result-oriented, flexibility, situational awareness, accuracy and do take initiative
  • Languages: English and Dutch is a must

Interview process: 2 stages interview process via On Site