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