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Quality Assurance

3 months ago

Hull, Kingston upon Hull, United Kingdom SHD Recruitment Full time

Main Areas of Responsibility:

  • Support the maintenance and development of the FPUK OMS in line with overall company quality objectives.

Support OP batch release related activities:

  • Coordination with QPs, Corporate QA and manufacturing sites

Administration of batch documentation (COAs, COCs etc.)

  • Review of batch documentation
  • Trending of QC data
  • Coordination with QC contract laboratories
  • Coordination with contracted Warehouse partners

Support the assessment and investigation of market complaints

  • Collaboration with outsourced partners most notably UK labs, UK warehouse/distributors, Corporate QA and manufacturing sites
  • Root cause analysis
  • Risk assessment and proposing suitable CAPAs
  • Report writing

Support continuous improvement across FPUK quality and occasionally at manufacturing sites

  • SOP writing
  • Development of complaint process in a digital first environment
  • Carrying out self inspections
  • Support Change contol and implementation of CAPAs

Support OP with final PQR review process.

If you believe you are suitable for this role, please proceed with your application.