Regulatory Compliance Specialist
2 weken geleden
As a Regulatory Compliance Specialist at Prothya Biosolutions, you will play a vital role in ensuring the highest standards of quality and safety in our end-to-end pharmaceutical production process. Our company is one of the few in the Netherlands that meets the stringent requirements of Good Manufacturing Practice (GMP).
About You
We are looking for an experienced professional with a strong background in cGMP environments to join our team. Your expertise in audit methods and techniques, pharmaceutical laws and regulations, and quality systems will be instrumental in driving our compliance efforts forward.
Key Responsibilities:
• Ensure thorough audits are conducted, assessing auditee's action plans for completeness, timeliness, accuracy, and alignment with our QMS.
• Identify bottlenecks with internal and external stakeholders and monitor follow-up measures to be taken.
• Translate annual departmental business objectives into actionable audit programs.
• Develop a deep understanding of existing and emerging regulatory GxP requirements within your area of expertise.
• Make informed decisions regarding GxP, including batch dispositions.
• Manage or provide advice on SOPs, GxP deviations, and change control.
• Stay up-to-date with mandatory GxP training and maintain accurate training records.
• Collaborate cross-functionally to ensure GxP compliance and contribute to writing SOPs.
Your Profile:
We seek a highly skilled individual with a Bachelor's degree in Life Sciences, Biology, Pharmacy, or related fields. Relevant experience in cGMP environments is essential, along with certification as an auditor or the ability to obtain it. Strong knowledge of audit methods, pharmaceutical laws, regulations, and quality systems is required.
What We Offer:
Full-time employment with a competitive salary range: €60,000 - €80,000 per annum (dependent on experience), 8.33% end-of-year bonus, 8.33% holiday allowance, flexible working hours, personal training budget, contribution to travel expenses, good accessibility by public transport, and private parking. We also offer a pension plan through Zorg & Welzijn.
Estimated Salary Range:€60,000 - €80,000 per annum
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