QA & PV Officer

  • Salary: Up to £28,000 per annum
  • REF Number: 00049926
  • Consultant:
  • Contact: 01438 842 966
  • Date Published: 18.02.2021
  • Sector:
  • Location: Manchester, North West
  • Discipline: Drug Safety And Pharmacovigilance, Regulatory Affairs

CK Group are recruiting for a QA & PV Officer to join an exciting pharmaceutical company on a permanent basis. This QA & PV Officer role will be a mix of office working in Manchester and home working.

QA & PV Officer Role: Assist the Head of Regulatory Affairs & Pharmacovigilance in the day-to-day running of the QA and PV departments. This will include review and maintenance of product quality records, PV data entry in safety databases, and working compliant to GMP, GPvP/GVP and GxP.

Responsibilities:

  • Compile and review batch release documentation in preparation for QP review and release.
  • Support QA team with internal audits, performing audits and compiling reports.
  • Support QA team in system management.
  • Collaborate with PV team to ensure reporting of Adverse Events.
  • Manage reporting and receipt of PV cases in EudraVigilance and the MHRA Submissions Portal.
  • Assist in the performance of signal detection activities and production of reports.
  • Review quality aspects, data and reports of products according to current legislations.

Your Background:

  • At least a University degree in a scientific discipline.
  • Some experience within PV, QA or Regulatory Affairs within a pharmaceutical company.
  • Awarenessof QA and PV processes and legislation.
  • Previous working with GMP, GPvP/GVP and GxP.
  • Excellent organisational skills with high attention to detail.
  • Strong IT skills.

Apply: For more information or to apply for this QA & PV Officer position, please contact Andy Leake by phone on 01438 842 966 or email on aleake@ckgroup.co.uk, quoting job ref 49926.

It is essential that applicants hold entitlement to work in the UK.

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