Job Title: Qualified Person (QP)
Department: Quality Assurance (QA)
Reporting to: Associate Quality Director
Responsible for (staff): None
General Purpose of Role:
- To QP certify manufacturing processes/activities performed under PCI Pharma Services MHRA licences.
- To review Batch Manufacturing Documents to ensure compliance with 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.
- To certify Medicinal Products for use in the EU and outside the EU (where relevant).
- To undertake audits in EU and third countries to ensure that sponsor manufacturing sites are operating in general compliance with EU GMP
- To provide advice and guidance to Biotec staff and Customers regarding QP requirements within the EU.
- To keep up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant).
- To review PCI Pharma Services Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and Biotec procedures.
- To provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI Pharma Services.
- Assistance with regulatory inspections and client audits.
- To agree and work towards 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.
Outcomes of Role:
- 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 Biotec procedures).
- Customer satisfaction with service (internal and external).
- 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.
Previous Work Experience:
- Experience working as a QP in the certification of sterile medicinal products in particular 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).
- Analytical thinking and Problem Solving
- Customer Service
- Judgement and decision making
- Self Confident
- Written communication
- Verbal communication
- Self Motivation/ achievement drive