QA Specialist

12331 · Livingston, West Lothian
Department 12331
Employment Type Full-Time
Minimum Experience Mid-level

QA Specialists

 

These are exciting times at Valneva!  As we continue to expand our business in Livingston, we are looking for a number of experienced QA Specialists.

 

The Role:

 

You will be assisting in developing and maintaining a comprehensive quality management system to achieve inspection readiness for Japanese Encephalitis Virus Vaccine (JEV), Coronavirus Vaccine (SARS-CoV-2) and other new products as required.  Additionally, you will act as Quality Assurance support for Valneva’s distribution network.

 

Your responsibilities will include:

 

  • Developing, monitoring, improving and maintaining procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals.
  • Performing activities and reviews in accordance with relevant Standard Operating Procedures, including but not limited to:
    • Risk assessments
    • Externally prepared documents
    • CAPA
    • Change requests
    • Deviations (including Quality Investigations, EME’s and OOS)
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • QMS data logs
    • Room release documentation
    • Batch record review (including PPRs, PTRs, MPRs and SPRs)
    • Fill / Finish documentation
    • Product defect reporting and Quality Investigations
    • Technical and Quality Agreements
    • Validation

 

  • Performing batch review duties in accordance with relevant procedures, including issuing Certificates of Non-Conformance for bulk drug product and review of QC batch test folders
  • Identifying, investigating and reporting quality issues, escalating to management as required
  • Participating in cross-functional projects
  • Developing, implementing and monitoring Continuous Improvement activities
  • Providing QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required
  • Co-ordinating and providing training across functional groups in Quality Procedures, cGMP requirements and QA concepts
  • Trend and report batch reviews and QMS data
  • Providing support to management during third-party audits
  • Performing internal housekeeping, in-process visits and quality audits
  • Performing external quality audits, supporting Livingston and other Valneva sites
  • Implementing and maintaining Quality Standard Operating Procedures, as required
  • Training staff in QA related procedures and concepts as directed by line manager
  • Undertaking any other duties as requested by the line manager in accordance with company requirements

 

What experience will you need?

 

  • Educated to degree level in relevant qualification or relevant experience
  • Proven and logical approach to problem solving
  • Previous QA experience
  • Experience of working effectively in a team, influencing as appropriate
  • Experience of working within a GMP manufacturing environment
  • Knowledge / experience of the requirements for distribution of pharmaceutical products

 

 

Your key skills will include:

 

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player

Thank You

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  • Location
    Livingston, West Lothian
  • Department
    12331
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level