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Quality & Compliance Coordinator Hoofddorp SIRE Life Sciences

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Gevraagd

  • 37 - 40 uur
  • Medior/Senior
  • Engels (taal)

Aanbod

  • Vast contract
 

Vacature in het kort

Hoofddorp
Our client, a pioneering biopharmaceutical company, is at the cutting edge of cancer treatment innovation, focusing on advanced immunotherapy. The role involves ensuring Quality Systems comply with regulations, overseeing the MRB system, and managing Change Control, Deviation, and CAPA systems. You'll support multidisciplinary initiatives, assist with regulatory inspections, and maintain cGMP documents. Join a team dedicated to shaping the future of medicine. Read on to see how your skills fit this role.
 

Over het bedrijf

SIRE Life Sciences
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The Company
Our client, a leading biopharmaceutical company specializing in innovative cell therapies. This company is at the forefront of developing ground-breaking cancer treatments, focusing on advanced immunotherapy solutions that help patients worldwide.

Role description:

  • Ensure Quality Systems comply with regulations and policies.

  • Oversee the MRB system, chair meetings, and manage communication.

  • Manage Change Control, Deviation, and CAPA systems, including training and administration.

  • Support multidisciplinary initiatives and Kite EU startup projects.

  • Assist with regulatory inspections and audits.

  • Maintain and approve cGMP documents.

  • Review and approve system and procedure changes.

  • Track, analyze, and report quality metrics for continuous improvement.

  • Perform other related tasks as needed.

Requirements:
  • Expert in GMP & Quality Systems (Change Control, CAPA, Audits, Deviations, MRB).

  • Experience in Aseptic Manufacturing and regulatory compliance.

  • Tech-Savvy – Proficient in MS Office & Quality Management Systems.

  • Education: Bachelor’s in Chemistry, Microbiology, Engineering, or similar.

  • Experience: 5+ years in Quality Assurance (GMP environment). ATMP experience is a plus.

  • Skills: Strong communication, problem-solving, and ability to work independently.

Other Information 

If you are interested in joining a team that is shaping the future of medicine, apply now via the link or contact Sofia Alftan. 


 

54751

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