Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 600 employees.
As we continue to expand our business in Livingston, we are looking for a number of experienced QA Specialists.
Your responsibilities will include:
- Developing, monitoring, improving and maintaining procedures to ensure compliance with EU/FDA Good Manufacturing Practice (GMP) for the manufacture and testing of pharmaceuticals.
- Performing activities and reviews in accordance with relevant Standard Operating Procedures (SOP), including but not limited to:
- Risk assessments
- Change requests
- Complaints (customer / supplier)
- Development Studies / Reports
- Batch record review
- Product defect reporting and Quality Investigations
- Technical and Quality Agreements
- 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, GMP requirements and QA concepts
- 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
- 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