Qualified Person (QP)
Job Title: Qualified Person (QP)
Department: Quality Assurance (QA)
Work Pattern: 40 hours per week
Reporting to: Quality Director
Responsible for (staff): N/A
To QP certify manufacturing processes/activities performed under PCI Pharma Services Medicines and Healthcare products Regulatory Agency (MHRA) licences. Key outcomes of the role include:
- Support to 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).
Essential Duties and Responsibilities:
- Review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- Review Batch Documents for all operations performed at PCI Pharma Services (PCI).
- Certify Medicinal Products for use in the EU and outside the EU (where relevant).
- Undertake audits in EU and third countries to ensure that Sponsor or Marketing Approval (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 EU.
- Keep up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant).
- Review PCI Project Files to ensure compliance with the current regulatory requirements and PCI’s procedures.
- Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Provide assistance with regulatory inspections and client audits.
- 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.
- Experience working as a QP in the certification of sterile medicinal products, in particular, Biopharmaceuticals manufactured aseptically.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC respectively.
- Extensive QA experience within the medicinal products/ pharmaceutical industry.
- GMP audit experience, preferably qualified as Lead Auditor
- Effective communication skills both verbal and written
- Good IT skills (at least MS Word)
- Strong analytical thinking and problem solving skills
- Customer service oriented
- Self confident, sound judgement and decision making skills
- Self motivated with drive to achieve outcomes
- Trustworthy and conscientious.