Compass Life Sciences have partnered with a rapidly expanding international vaccine biotech. This is an exciting role for someone to join a newly built manufacturing building, enhance their career and be part of a global effort against disease. You will be provided with the opportunity for personal growth and development all while encouraging work-life balance. The successful candidate will have relevant Quality Assurance experience and knowledge of pharmaceutical distribution requirements. The QA Specialist will be available to start work between now and March. The Role To assist in developing and maintaining a comprehensive quality management system to achieve inspection readiness for vaccines. Additionally, you will act as Quality Assurance support for the distribution network. 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 review 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 Required skills 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 Attention to detail Excellent organisational skills Effective communication skills Flexible and adaptable team player If you are an experienced QA and seeking your next role apply now.  To find out more contact Zoe Pindar-Ark at zpindarark@compassltd.co.uk or +161 870 8996 Recommendations Alternatively, recommend someone you think is suitable. Compass Associates Ltd trading as Compass Life Sciences is acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation.