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Salary 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:
- To review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- To review Batch Documents for all operations performed at PCI Pharma Services (PCI).
- To certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
- 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
- To provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
- To keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of the world (where relevant).
- To review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
- To provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Assistance with regulatory inspections and client audits.
- To agree and work towards the achievement of personal development goals
- Where required, undertake departmental tasks and projects outside the job holder’s area of responsibility in line with departmental and senior management team objectives.
- Where required deputise for the Lead Qualified Person.
- From time to time, the above listed duties may be undertaken at other PCI facilities, in particular PCI sites located in Ireland. In such cases, the person will be responsible for ensuring they are properly trained in the local PCI site procedures and that their training record is maintained and up to date.
- The scope of the activities undertaken at PCI Ireland is limited to projects managed or distributed from the PCI Bridgend facility currently and will assist PCI manage Brexit outcomes.
- Perform Supply Chain Oversight when required.
Outcomes of Role:
- Support the Quality Assurance Department in managing the QMS and assisting in quality investigations.
- Ensure continued compliance, operationally, to PCI Pharma Services licences for Marketed Products, Investigational Medicinal Products and unlicensed medicines (Specials – as per PCI Bridgend (and/or Ireland) procedures).
- Customer satisfaction with service (internal and external).
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.
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.
