Quality Associate
Current• Application of PIC/S Guidelines for GMP and the Therapeutic Goods Act 1989 to all aspects of the manufacture of sterile medicinal products.• Customer complaint investigation, root cause analysis, CAPAs, customer responses. • Management of certification and calibration of facilities, plant, and equipment.• Creation of monthly KPI reports and yearly Product Quality Reviews.• Managing change control, including procedural and documentation reviews.• Impact and risk assessment of preventative and breakdown maintenance.• Participation in regulatory conformance audits.