QA Specialist- Regulatory Affairs

Job description

Job Description Summary The Systems QA Specialist provides Quality System (QMS) support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment. The role focuses on strengthening and maintaining compliant quality systems that enable safe, effective, and timely product supply. Working cross-functionally with Manufacturing, Engineering, Validation, QC Microbiology/QC Labs, and Supply Chain, the Systems QA Specialist supports site performance through robust documentation, change control, deviation/CAPA management, risk management, and inspection readiness. This is a support role (not final release authority). The role contributes to quality decisions through thorough assessment, escalation, and documentation in line with site procedures. Job Description: Responsibilities: QMS Management & System Oversight (Primary Focus) Support end-to-end execution of core QMS processes within assigned areas: Deviations/Nonconformances, CAPA, Change Control, Risk Assessments, Document Control, and Training Compliance. Ensure QMS records are initiated, assessed, progressed, and closed within SLA and meet data integrity and GDP expectations....