Valneva

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