Support regulatory inspections/audits, providing dynamic assistance to SME's. * Manage and follow-up of Deviations, OOS, Failure Investigations, Change Control, Qualification/Validation, Compliance Audit activities, Stability program, Lab Critical Materials, and documentation approval related to the PSQC Processes & Operations. * Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements. * Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP. * 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 ...
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