Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.

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

The Role

To assist 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 review 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
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