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 granu

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