Testing Coordinator

2 dagen geleden

Leiden, Zuid-Holland, Nederland Panda International Voltijd

Job Role:
Testing Coordinator (Sr. Ass. Scientist)

About the Role:

We are seeking an experienced Testing Coordinator (Sr. Ass. Scientist) to join our Analytical Development team in Leiden, The Netherlands. This role focuses on coordinating all GMP and non-GMP testing, both in-house and outsourced, for release, stability, and characterization of products in development. You will act as a key contact for internal and external stakeholders, ensuring compliance with quality standards and supporting efficient, accurate, and timely testing processes.

Key Responsibilities:

  • Coordinate GMP and non-GMP testing internally and at external CROs.
  • Oversee execution of internal testing related to release, stability, (re)qualification of RMCR, and late-stage product/process characterization.
  • Manage inspection, release, and change control for production raw materials, lab chemicals, and lab supplies.
  • Handle GMP sample and material management.
  • Support environmental and utility monitoring of the GMP production plant.
  • Manage GMP qualification of laboratory equipment and computerized systems.
  • Maintain and develop GMP and non-GMP data systems to ensure data integrity and efficient data processing.
  • Act as subject matter expert during regulatory inspections, internal audits, and external GMP audits.
  • Serve as first point of contact for internal stakeholders (production sites, project managers, stability scientists) and external partners (CROs, CMOs).

Key Competencies:

  • Strong knowledge of GMP regulations, CMC processes, and laboratory/compliance management systems (e.g., eLims, Veeva Vault).
  • Excellent cross-functional collaboration, communication, and interpersonal skills.
  • Ability to prioritize work effectively and handle multiple projects simultaneously.
  • Continuous improvement mindset (e.g., lean thinking).
  • Strong attention to detail and problem-solving skills.
  • Ability to maintain confidentiality and act with integrity.

Requirements:

  • HBO-level degree in a life science discipline.
  • 5–10 years of experience in a pharmaceutical environment, preferably within CMC.
  • At least 5 years of relevant experience in process coordination.
  • At least 5 years of GMP experience.
  • Highly proficient in spoken and written English; Dutch is a strong plus.

Practical Information:

  • Location:
    Leiden, The Netherlands
  • Duration:
    1-year contract
  • Start Date:
    ASAP
  • Work Model:
    On-site

Interested or know someone who might be?

Send your CV or inquiries to
e.-
to apply or learn more.

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