Girishkumar Chavda

Led QA and RA functions to maintain compliance for API manufacturing. Completed DMF submissions and regulator follow-ups, and drove WHO-GMP, Written Confirmation, and ISO 9001:2015 readiness.

Managed end-to-end QA/QC operations for API products, improving quality systems and audit readiness. Oversaw vendor qualification, customer audits, CAPA, APQR, and achieved FSSC 22000 with multiple customer approvals.

Reviewed and approved validation work, batch records, and product specifications to ensure consistent product quality. Managed OOS findings, deviations, and customer complaint closures.

Directed QA/QC for API manufacturing, strengthening overall quality control. Led validation and stability programs, supported DMF preparation, and coordinated inspections including USFDA, COFEPRIS, and WHO.

Led equipment qualification (IQ, OQ, PQ) and produced complete qualification reports. Developed QA procedures, validation planning documents, stability and qualification studies, and ensured supplier and batch release approvals.

Managed QA/QC operations for API manufacturing, including internal audits, documentation control, and DMF-related activities. Supported successful audits by major Indian pharma companies and contributed to GMP and State GMP certification processes.

Managed end-to-end QA/QC for solid and liquid oral dosage manufacturing. Executed process and cleaning validations, vendor qualifications, and supported WHO-GMP and ISO certification initiatives.

Prepared SOPs and equipment qualification documents, including verification protocols and reports. Reviewed BMR, SOPs, IQ/OQ/PQ, and QC STPs and supported ongoing plant activities.

Reviewed BMRs, departmental SOPs, QC STPs, and product specifications. Managed change control and audits, prepared protocols/reports for process and cleaning validation and water system checks, and handled returned goods.

Created RM/FP/PM specifications and prepared MFC, MBR, and BPR documents to support manufacturing. Conducted sampling and testing of raw materials, packaging, and finished products and prepared stability and product approval documentation.

Performed incoming material sampling and analysis and tested tablets, ointments, syrups, injections, capsules, and external liquids. Conducted glassware checks and prepared/standardized volumetric solutions in support of QC testing.

Completed an M.Sc. in Chemistry at Madurai Kamaraj University from 2004 to 2007.

Completed a B.Sc. in Chemistry at South Gujarat University from 1993 to 1997.