Quality Systems & Compliance Manager

Document Data Management Ensure all controlled documentation is current, accurate, relevant and accessible. Review and approve new/updated procedures and quality documentation. Ensure quality records are complete, legible and compliant with good documentation practice. Quality System Oversight Report monthly quality KPIs to the Aseptic Compounding Management Team.

Review QA data, quality documentation, and compile reports. Ensure quality data (including CAPA, Complaints, deviations, etc.) is tracked, trended and monitored for timely completion. Champion risk identification and management across the unit. Audit Management Lead internal audits and coordinate responses to external, regulatory and customer audits.

Drive investigation of audit findings and ensure corrective actions are delivered promptly and effectively. Strong knowledge of Quality System processes Working knowledge of EU/UK GMP Experience in Document Control, Internal Audit, CAPA, Nonconformance and Complaints processes Problem-solving tools such as 8D, GEMBA, 5 Whys, Cause Effect Internal auditing experience