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 is 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, and to act as Quality Assurance support for Valneva's distribution network.
Requirements
* Proficient and accurate in batch documentation/electronic records review, and in reviewing and approving QE, including conducting effectiveness checks, focusing on batch release and certification documentation for QP release.
* Assist with 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 reviewing 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.
* Identify areas for continuous improvement or Total Quality Management (TQM) and report progress to the Manager, QA Operations.
* Actively contribute to a supportive and collaborative environment within the QA Operations team and QA Department.
* Undertake any other duties in accordance with company requirements.
* Participate 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 and functional QA when required.
* Coordinate and provide training across functional groups in quality procedures, cGMP requirements, and QA concepts.
* Support trending and reporting of batch review and QMS data.
* Assist management during third‑party audits.
* Perform internal housekeeping, in‑process visits, and quality audits.
* Support external quality audits, including at 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 the line manager.
* Work normally during regular hours; overtime/out‑of‑hours work may be required in QA Operations at the discretion of the line manager.
Benefits
* Stock options
* Employee Assistance Programme
* Gym membership or fitness allowance
* EV salary sacrifice
* Many additional benefits included
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