Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Policies & Procedures * Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements. * Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc) * Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI's and product/process quality. * Proven understanding of QC processes: stability studies, material management, specification management. * Experience with Quality Management System and Internal/External Auditing
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