Regulatory Compliance Specialist
2 weeks ago
We are PCI Pharma Services, a company that invests in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The General Purpose of this Role is to certify manufacturing processes and activities performed under PCI Pharma Services MHRA licenses, ensuring compliance with UK and EU GMP and the Product Specification File/marketing authorization.
Main Responsibilities- Review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorization.
- Review Batch Documents for all operations performed at PCI Pharma Services.
- Certify Medicinal Products for use in the UK, EU, and outside the EU.
- Undertake audits in the UK, EU, and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
- Keep up to date with the requirements of the Medicines Authorities across the UK, EU, and rest of world.
- Review PCI Project Files to ensure compliance with current regulatory requirements and PCI procedures.
- Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Assistance with regulatory inspections and client audits.
- Perform Supply Chain Oversight when required.
Eligible 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 2001/83/EC and 2001/20/EC respectively.
Previous Work Experience: Experience working as a QP in the certification of sterile medicinal products, particularly Biopharmaceuticals manufactured aseptically.
Specific Knowledge / Skills Competence:
- Extensive QA experience within the medicinal products/pharmaceutical industry.
- GMP Audit experience preferably qualified as Lead Auditor.
- Experience in Biopharmaceuticals.
- Experience in Sterile manufacture.
- Effective Communication skills.
- Good IT skills (at least MS Word).
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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