Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is 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.
General Purpose of Role: To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.
Main Responsibilities:
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To review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
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To review Batch Documents for all operations performed at PCI Pharma Services (PCI).
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To certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
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To 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
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To provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
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To keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).
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To review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
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To provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
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Assistance with regulatory inspections and client audits.
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Perform Supply Chain Oversight when required.
Specific Qualifications:
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 in particular Biopharmaceuticals manufactured aseptically.
Specific Knowledge / Skills Competence:
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Extensive QA experience within the medicinal products/ pharmaceutical industry.
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GMP Audit experience preferably qualified as Lead Auditor
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Experience in Biopharmaceuticals
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Experience in Sterile manufacture
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Effective Communication skills
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Good IT skills (at least MS Word).
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
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.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
