Girishkumar Chavda

Senior Pharmaceutical Quality Leader with 28 years of progressive experience in Quality Assurance, Quality Control and Regulatory Affairs across API and Finished Formulation manufacturing. Extensive experience in establishing and maintaining Pharmaceutical Quality Systems (PQS), ensuring compliance with cGMP, WHO-GMP, EU-GMP and US FDA expectations, and leading regulatory inspections. Proven expertise in Quality Management Systems, Validation, Qualification, Data Integrity, CAPA, Change Control, Risk Management, Stability Programs, DMF preparation and regulatory compliance.

Experienced in leading multidisciplinary teams and driving continuous quality improvement.

Head Quality Assurance & Regulatory Affairs - BMS Chemie - Vadodara

(2024-05)

• Lead Quality Assurance and Regulatory Affairs functions.
• Oversee QA and QC activities for API manufacturing.
• Manage DMF submissions and regulatory interactions.
• Lead validation, vendor qualification, QMS implementation and inspection readiness.
• Drive GMP compliance and continuous quality improvement.

Manager – QA & QC - Shanpar Industries Pvt. Ltd. - Vadodara

(2019-08 - 2024-05)

• Managed complete QA and QC operations for API manufacturing.
• Led vendor qualification, customer audits and CAPA implementation.
• Directed APQR, validation activities and quality system improvements.
• Supported successful certification and customer approvals.

Manager – QA & QC - Ambika Chemicals Pvt. Ltd. - Ankleshwar

(2018-08 - 2019-08)

• Approved process/method validation protocols, batch manufacturing records (BMR), and raw/finished product specifications.
• Led root-cause analysis and investigation workflows for OOS/OOT findings, process deviations, and customer complaints.
• Managed QA/QC operations.

Manager – QA & QC - Abhilasha Pharma Pvt. Ltd. - Ankleshwar

(2015-05 - 2018-06)

• Directed QA and QC activities.
• Managed validation and stability programs.
• Supported Drug Master File preparation.
• Coordinated regulatory inspections.

Head – QA - Entrance Industries & Research Center - Accra, Ghana

(2013-05 - 2015-02)

• Developed Validation Master Plan and Site Master File.
• Led qualification of equipment and utilities.
• Implemented QA systems and SOPs.
• Managed stability, cleaning validation and supplier approvals.

QA Manager - Oneiro Chemicals Pvt. Ltd. - Vadodara

(2012-06 - 2013-04)

• Managed QA/QC systems for API manufacturing.
• Controlled documentation, internal audits and DMF activities.

QA Manager - Shine Pharmaceutical Pvt. Ltd. - Vadodara

(2008-06 - 2012-05)

• Led QA/QC for oral solid and liquid dosage manufacturing.
• Managed process validation, cleaning validation and vendor qualification.

QA Executive - Sterling Biotech Ltd. - Vadodara

(2006-11 - 2008-07)

• Drafted SOPs, qualification protocols (IQ/OQ/PQ), and verification reports for manufacturing and analytical equipment.
• Conducted routine plant compliance rounds, batch record reviews, and laboratory analytical method verifications.

QA Officer - Zydus Cadila Healthcare Ltd. - Vadodara

(2004-03 - 2006-11)

• Prepared protocols and final reports for process validation, cleaning validation, and water system qualification.
• Executed BMR/BPR reviews, APQR compilation, vendor evaluation, change control tracking, and customer complaint closures.

QA/QC Executive - Gujarat Liqui Pharmacaps Pvt. Ltd. - Vadodara

(2001-04 - 2004-03)

• Developed material specifications, Master Formula Cards (MFC), and Batch Packaging Records (BPR).
• Prepared technical dossiers for international product registrations (including NAFDAC, Nigeria), C.O.P.P., and Free Sale Certificates.
• Conducted sampling, testing, stability studies, and WHO-GMP readiness assessments.

Analytical Chemist - ICPA Health Products Pvt. Ltd. - Ankleshwar

(1998-02 - 2001-04)

• Performed sampling, physical/chemical testing, and volumetric solution standardization for raw materials and finished products (Tablets, Capsules, Liquids, Ointments, Injections).
• Handled calibration of analytical instruments and laboratory glassware.

Master of Science - Chemistry - Madurai Kamraj University (2004-06 - 2007-04)

Bachelor of Sciences - Chemistry - South Gujarat University (1993-06 - 1997-04)