Lead and manage the Quality Assurance department across manufacturing, packaging, warehouse, and laboratory operations.
Develop, implement, and continuously improve the Quality Management System (QMS).
Ensure compliance with cGMP, WHO-GMP, US FDA, EU GMP, MHRA, TGA, PIC/S, and other applicable regulatory requirements.
Review and approve Standard Operating Procedures (SOPs), Master Batch Records (MBRs), validation protocols, qualification documents, and quality documentation.
Oversee investigations related to deviations, OOS, OOT, change controls, CAPA, and risk assessments.
Lead internal, customer, and regulatory audits and ensure timely closure of audit observations.
Provide strategic direction for process validation, cleaning validation, equipment qualification, and computerized system validation.
Review and approve Annual Product Quality Reviews (APQR/PQR).
Ensure timely batch disposition and product release.
Drive data integrity initiatives and foster a quality culture throughout the organization.
Collaborate with Manufacturing, QC, Engineering, Regulatory Affairs, Supply Chain, and R&D to ensure product quality and compliance.
Mentor and develop QA teams, ensuring high performance and succession planning.
Monitor quality metrics and implement continuous improvement initiatives.
