Auditor - Quality Assurance Specialist

3 dagen geleden

Amsterdam, Noord-Holland, Nederland Prothya Biosolutions Voltijd

Your role:

As a GxP Auditor at Prothya Biosolutions, you will be responsible for ensuring the quality and integrity of our pharmaceutical products. This involves conducting audits to verify compliance with regulatory requirements and company policies.

Your responsibilities:

  • Design, execute, and manage audits to ensure compliance with GxP regulations and company policies.
  • Assess the auditee's action plan for completeness, timeliness, accuracy, and alignment with Prothya's QMS.
  • Identify bottlenecks with internal and external stakeholders and monitor the follow-up of measures to be taken.
  • Translate annual departmental business objectives to the audit program.
  • Have a broad and in-depth understanding of existing and emerging regulatory GxP requirements within your field of expertise.
  • Make decisions regarding GxP, such as batch dispositions.
  • Manage or provide advice on SOPs, GxP deviations, and change control.
  • Follow mandatory GxP training and maintain an appropriate training record.
  • Interact cross-functionally to ensure GxP compliance and write SOPs.
  • Take GxP requirements into account during preparation, execution, and reporting of GxP activities.

Your profile:

  • Bachelor's degree in Life Sciences, Biology, Pharmacy, or a related field.
  • Several years of experience in a cGMP environment.
  • Certification as an auditor or the ability to obtain this certification.
  • Knowledge of audit methods and techniques, pharmaceutical laws and regulations, and quality systems.
  • Flexibility to travel inside and outside the Netherlands.
  • High level of English proficiency.

About Prothya Biosolutions:

Prothya Biosolutions is a leading end-to-end pharmaceutical company in the Netherlands. Our production process meets the highest requirements as laid down in the GMP. Quality and safety are regularly checked by Dutch and international authorities.

What we offer:

  • Full-time employment.
  • 8.33% end-of-year bonus and 8.33% holiday allowance.
  • Flexible working hours in consultation.
  • Personal training budget of €2,000 per 3 years.
  • Contribution to travel expenses from the first kilometer.
  • Good accessibility by public transport and private parking.
  • Pension plan at Zorg & Welzijn.

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