Regulatory Compliance Specialist
7 days ago
At PCI Pharma Services, we are committed to making a global impact in the biopharma industry. As a Regulatory Compliance Specialist - QP Certification, you will be part of our team that pioneers and shapes the future of pharmaceutical manufacturing.
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience.
Job DescriptionGeneral Purpose of Role: To ensure compliance with UK and EU GMP regulations in the certification of manufactured products.
Main Responsibilities:
- Review Batch Manufacturing Documents for compliance with UK and EU GMP regulations.
- Certify Medicinal Products for use in the UK, EU, and third countries.
- Undertake audits to ensure Sponsor or MA Holder manufacturing sites comply with EU GMP regulations.
- Provide advice and guidance to staff and customers on QP requirements within the UK and EU.
- Keep up-to-date with regulatory requirements across the UK, EU, and rest of world.
- Review PCI Project Files to ensure compliance with current regulatory requirements and PCI procedures.
- Contribute to the development and implementation of Quality Management Systems at PCI.
- Support regulatory inspections and client audits.
- Perform Supply Chain Oversight when required.
To be successful in this role, you must have:
- Eligibility to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with UK legislation and EU directives.
- Experience working as a QP in the certification of sterile medicinal products, particularly Biopharmaceuticals manufactured aseptically.
- Extensive QA experience within the medicinal products/pharmaceutical industry.
- GMP Audit experience, preferably as Lead Auditor.
- Effective communication skills and good IT skills (at least MS Word).
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