QA & PV Officer
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.
- 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.
- 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 email@example.com, quoting job ref 49926.
It is essential that applicants hold entitlement to work in the UK.