QA Specialist

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.

Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

Our Quality Assurance team are now recruiting for a QA Specialist within the Operations team.

Primary responsibility will be to perform routine batch review and certification activities to support the QP batch release. To assist in developing and maintaining a comprehensive quality management system to achieve inspection readiness. Additionally, act as Quality Assurance support for Valneva’s distribution network.

Requirements

• To be proficient and accurate in batch documentation / electronic records review as well as on the review and approval of QE (including conducting effectiveness checks, as required), with particular focus on the generation, review and approval of batch release and certification documentation for QP release.
• To assist with the preparation of the Annual Product Quality Review (APQR).
• Perform batch record and documentation review duties in accordance with relevant procedures, including issuing
• Certificates of Non-Conformance for bulk drug product and review of QC batch test folders
• Identify, investigate and report quality issues, escalating to management as required
• Develop, monitor, improve and maintain procedures to ensure compliance with EU Good Distribution Practice for pharmaceutical products
• To identify areas of, escalate and implement solutions for, continuous improvement or Total Quality Management (TQM) and report progress back to the Manager, QA Operations.
• To actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the QA Operations team and QA Department team setting.
• To undertake any other duties in accordance with company requirements
• Perform batch review and certification activities in accordance with relevant Standard Operating Procedures,
• Participation in cross-functional projects
• Develop, implement and monitor Continuous Improvement activities
• Provide QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required
• Co-ordinate and provide training across functional groups in Quality Procedures, cGMP requirements and QA concepts
• Supporting trending and report batch review and QMS data
• Provide support to management during third-party audits
• Perform internal housekeeping, in-process visits and quality audits
• Provide support with external quality audits, supporting Livingston and other Valneva sites
• Implement and maintain Quality Standard Operating Procedures, as required
• Train staff in QA related procedures and concepts as directed by line manager
• To undertake any other duties as requested by the line manager in accordance with company requirements
• Although overtime and out-of-hours work is not normally required, it is required in QA Operations and theincumbent is expected to support on request.

Benefits

• Stock Options
• Employee Assistance Programme
• Gym membership OR fitness allowance
• EV Salary Sacrifice
• Many others included