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Qualified Person (QP)

Job Title: Qualified Person (QP)
Location: Bridgend
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.

Main Responsibilities:

  • 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).

Specific Qualifications:

  • 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).

Behavioural Competencies:

  • Analytical thinking and Problem Solving
  • Customer Service
  • Judgement and decision making
  • Self Confident
  • Written communication
  • Verbal communication
  • Self Motivation/ achievement drive
  • Trustworthiness
  • Conscientiousness
Posted on Categories EU, EU Bridgend, Vacancies

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