Key Responsibilities Quality Systems Management • Implemented and maintained the Quality Management System (QMS) ensuring compliance with global regulatory standards. • Conducted investigations for Deviations, Corrective and Preventive Actions (CAPA), and Market Complaints, ensuring timely root cause analysis and effective preventive measures. • Initiated, reviewed, and closed Change Controls, Deviations, and CAPA within e-QMS systems. • Conducted risk assessments and contributed to continual improvement in compliance processes. • Prepared and reviewed quality documents, SOPs, and reports summarizing trends, findings, and compliance status. Audit and Compliance • Monitored IPQA activities, ensuring adherence to cMP standards during in-process stages. • Coordinated and participated in self-inspections, customer audits, and regulatory inspections, ensuring timely implementation of corrective actions. • Ensured ongoing regulatory compliance across manufacturing and documentation activities. • Maintained communication and responses to Drug Authorities and government departments for audit Validation and Qualification • Prepared and reviewed Qualification Protocols for URS, FAT, SAT, IQ, OQ, and PQ. • Supported equipment and process validation including deaning validation and transport validation. • Ensured equipment and systems met regulatory expectations for performance, safety, and quality. Training & Development • Designed and delivered training programs on GMP, GDP, and Data Integrity to enhance employee competence and regulatory awareness.Acted as a certified interal trainer ensuring effective knowledge transfer and consistent quality culture. • Trained and motivated QA and production teams to achieve operational excellence and compliance consistency. • Coordinated with Production, QC, and engineering teams for process improvements and operational efficiency. Manufacturing & Operational Oversight • Supervised and planned manufacturing operations including granulation, compression, coating. capsule filling, dry syrup filling, and inspection areas. • Ensured that manufacturing processes complied with approved procedures, process parameters, and quality standards. • Coordinated with production, QC, and engineering teams for process improvements and operational efficiency. Quality Assurance & Continuous Improvement • Created and implemented company-wide quality standards at Loan License sites, ensuring uniform • Contributed to achieving QA operational objectives by monitoring policies, enforcing SOPs, and ensuring quality compliance. • Supported budget estimation, resource planning, and financial control for QA activities. • Conducted hazard analysis and developed quality assurance plans for critical manufacturing and testing processes. • Led continuous improvement initiatives to optimize QMS effectiveness, reduce errors, and strengthen compliance.