Global Quality Operations Manufacturing Senior Specialist

15 uur geleden

Amsterdam, Noord-Holland, Nederland Planet Pharma Voltijd

Job Description
Join Our Team as a Global Quality Operations Manufacturing Senior Specialist

Are you a seasoned quality professional seeking a dynamic role in the biotech manufacturing landscape? We are looking for a dedicated and detail-oriented Global Quality Operations Manufacturing Senior Specialist to play a pivotal role in ensuring the highest standards of GMP compliance and quality in ATMP manufacturing. This 6-month consulting opportunity offers you the chance to contribute to innovative projects, optimize quality processes, and work within a collaborative environment that values your expertise.

What You Will Do

  • Review and oversee ATMP manufacturing batch records to ensure accuracy and compliance
  • Manage deviations, CAPAs, and change control processes to uphold quality standards
  • Monitor and review clinical batches across connected DMUs, ensuring adherence to GMP regulations
  • Serve as QA representative for Kitting, SAP-related activities, and supply chain processes, including batch review and SAP release of kits
  • Oversee SAP BOM activation/inactivation, audit trails, and procedure approvals related to Kitting and Supply Chain
  • Facilitate block/unblock activities and manage return shipments logs for effective quality control
  • Identify opportunities for continuous improvement in GMP manufacturing processes

Required Skills

  • Bachelor's or Master's degree in Biology, Biotech Sciences, Chemistry, or related field
  • 3-5 years of experience working within a GMP environment, with a solid understanding of cGMP QA processes
  • Proven experience in ATMP manufacturing and commercial GMP settings
  • Strong knowledge of deviations, CAPAs, change controls, and QA documentation
  • Excellent attention to detail and problem-solving skills
  • Effective communication and collaboration abilities

Nice To Have Skills

  • Experience with SAP systems, particularly in a GMP manufacturing context
  • Familiarity with clinical batch review processes
  • Prior involvement in quality management activities related to kitting and supply chain

Preferred Education And Experience

  • Bachelor's degree in a relevant scientific discipline; Master's degree preferred
  • 3 to 5 years of hands-on GMP QA experience, ideally within ATMP or cell therapy manufacturing

Other Requirements

  • Willingness to work in Leiden on a full-time basis for the duration of the contract
  • Ability to coordinate across multiple departments and manage documentation rigorously
  • Knowledge of industry regulations and compliance standards

If you're ready to leverage your expertise in a challenging and rewarding environment, we encourage you to apply now. Join us in shaping innovative therapies and making a meaningful impact in healthcare

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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