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Senior Quality Assurance Associate

4 weken geleden

Nederland Panda International Voltijd

Together with a leading biotechnology company , we are looking for a Sr. Associate QA, Product Complaint Inspection (PCI) to support product complaint investigations, ensure regulatory compliance, and contribute to continuous quality improvements. This role involves managing deviations, maintaining quality processes, and collaborating with cross-functional teams.

Key Responsibilities

  • Conduct product complaint assessments , including return sample inspections and safety feature verifications.
  • Collaborate with global quality teams, assessors, and external partners to resolve complaint investigations.
  • Support regulatory inspections and audits related to complaint sample handling.
  • Initiate and manage minor deviations related to PCI activities.
  • Ensure compliance with GMP, GDP, and internal quality standards .
  • Review and approve procedures and work instructions in alignment with corporate and regulatory requirements.
  • Develop and maintain training materials and work instructions for PCI processes.
  • Provide training to site and affiliate staff on investigation and assessment procedures .
  • Prepare and maintain departmental performance metrics and reporting boards.
  • Support site projects and quality improvement initiatives related to complaint handling.
  • Gain subject matter expertise in product complaint inspections and contribute to process enhancements.

Qualifications

  • MBO or Bachelor’s degree in Life Sciences or a related field (or equivalent experience).
  • At least 2 years of GMP experience in the pharmaceutical or biotechnology industry.
  • Minimum 2 years of Quality Assurance experience , preferably in complaint management, deviations, or quality systems.

Skills & Competencies

  • Strong understanding of GMP and GDP regulations.
  • Knowledge of quality systems, deviations, and complaint investigations .
  • Ability to work independently while collaborating across teams.
  • Fluent in English (written and spoken).

Practicalities

  • Contract: 1-year contract with the possibility of extension.
  • Work Type: Fully on-site role.
  • Language: English.
  • Location: Breda, Netherlands.

INTEREST?

If you’re interested in the above please apply with your CV today. For further information, please contact Daria +31202044502 or by email at d.finikova@panda-int.com