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 * Support regulatory inspections/audits, providing dynamic assistance to 's. * Oversee critical global activities to ensure analytical operations are conducted in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) * 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. * Ensure supporting QC routine operations maintain adequate cGMP standards
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