Head Quality Assurance - ASTRAL SteriTech Pvt. Ltd. - Vadodara, Gujarat
(2026-01 - 2026-03)
- Leading full QA facility startup for sterile dry powder Injectable formulation plant—overseeing regulatory readiness from ground up.
- Authored and released complete documentation suite: SMF, VMP, SOPs, and qualification / validation protocols aligned to WHO and USFDA standards.
- Built and recruited a multi-functional QA team from scratch, establishing reporting structures and training programs to ensure compliance-ready operations.
- Driving cGMP- WHO and USFDA certification readiness for the facility.
Head Quality Assurance - Harson Laboratories India Pvt. Ltd. - Vadodara, Gujarat
(2025-06 - 2026-01)
cGMP-WHO Certified facility. Project Role (6 Months).
- Successfully cleared regulatory and customer audits with all CAPA observations closed within committed timelines and zero repeat findings.
- Authored complete regulatory documentation: SMF, VMP, SOPs, and qualification / validation protocols for WHO-certified sterile facility.
- Operated PharmaCloud ERP system for end-to-end QMS documentation, including material inward / outward verification and batch record management.
- Partnered with external agency to lead Computer System Validation (CSV)—ensured all documentation met regulatory expectations with no deviations at audit.
- Developed and implemented comprehensive QA programs that measurably improved product quality scores and customer satisfaction tracings.
General Manager – Quality Assurance - Universal Medicap Ltd. - Vadodara, Gujarat
(2023-10 - 2025-02)
ISO 15378 Certified facility (17 Months).
- Cleared ISO 15378 and customer audits; delivered timely CAPA compliance for all observations with zero escalations.
- Led raw material and in-process inspection programs, removing non-conforming products/materials and achieving consistent batch acceptance rates.
- Prepared and maintained regulatory documentation: SMF, VMP, SOPs, and qualification / validation protocols.
- Championed PharmaCloud ERP implementation—partnered with IT team on system rollout and proper QA documentation integration.
- Developed and sustained QA processes that delivered improved product quality and customer satisfaction across all product lines.
General Manager – Quality Assurance (Head QA) - Harson Laboratories India Pvt. Ltd. - Vadodara, Gujarat
(2020-05 - 2023-04)
EU GMP Sterile Injectable Facility (36 Months).
- Faced and successfully cleared EU GMP/PIC'S consultant and customer audits — zero critical observations; CAPAs closed within agreed timelines.
- Authored complete EU GMP-compliant documentation: SMF, VMP, SOPs, and qualification / validation protocols for the sterile injectable facility.
- Led CSV initiative with external agency across 12+ computer systems, ensuring compliant documentation with no audit findings.
- Coordinated with RA team to prioritise and expedite product-related document submissions, supporting multiple market approvals.
- Implemented QA programs that ensured all deliverables met the highest quality standards under EU GMP regulatory requirements.
Senior Manager – Quality Assurance - Shukra Pharmaceuticals Ltd. - Gandhinagar, Gujarat
(2019-04 - 2020-03)
cGMP-WHO Certified facility.
- Prepared SMF, VMP, SOPs, and qualification / validation protocols for cGMP- WHO facility.
- Conducted thorough material inspections prior to production ensuring quality and authenticity at every stage.
- Operated PharmaCloud ERP for material verification and QMS documentation.
- Provided CSV documentation support with external agencies and RA query resolution.
Senior Manager – Quality Assurance - Acme Pharmaceuticals Pvt. Ltd. - Ahmedabad, Gujarat
(2017-04 - 2019-04)
GMP-WHO Certified, Zydus Cadila Associated (24 Months).
- Managed QA operations for sterile liquid Injectable SVP dosage forms manufacturing.
- Authored and maintained SMF, VMP, SOPs, and validation documentation.
- Facilitated CSV with external agencies; operated Pharmasuite ERP or QMS and material verification.
- Implemented QA improvement programs that significantly raised product quality metrics across sterile Injectable lines.
Manager – Quality Assurance - Brooks Laboratories Ltd. - Vadodara, Gujarat
(2014-09 - 2017-02)
Sterile Formulation – Beta-lactam Carbapenem (30 Months).
- Led QA project work for a new sterile Beta-lactam Carbapenem facility from the ground up—system design through audit readiness.
- Cleared customer and consultant audits with timely CAPA compliance across all observations.
- Operated ERP systems for material management entries and QMS documentation; supported CSV with external agencies.
Manager – Quality Assurance - Elysium Pharmaceuticals Ltd. - Vadodara, Gujarat
(2012-03 - 2014-09)
cGMP-WHO Certified (31 Months).
- Cleared third-party, licensing, and client audits; ensured CAPA compliance for all observations with in committed timelines.
- Authored SMF, VMP, SOPs, and qualification / validation protocols.
- Supported RA team with product-related document submissions and query resolution.
Manager – In-Process Quality Assurance (IPQA) - Claris Life Sciences Ltd. - Ahmedabad, Gujarat
(2010-04 - 2012-03)
cGMP-WHO, USFDA, MHRA, TGA Certified (24 Months).
- Oversaw in-process quality checks as per SOPs for liquid Injectable SVP & LVP products across USFDA, MHRA, and TGA certified lines.
- Monitored in-process activities continuously to ensure compliance with multi-regulatory quality standards.
- Developed and implemented comprehensive IPQA programs across multiple product lines.
Senior Executive – Quality Assurance - ASTRAL Pharmaceuticals Industries - Vadodara, Gujarat
(2008-08 - 2010-04)
cGMP-WHO & USFDA Certified (21 Months).
- Ensured in-process and finished product quality for cGMP-WHO and USFDA certified manufacturing operations.
- Implemented in-process QA programs achieving ~95% improvement in product quality metrics.
- Provided RA support for product-related document submissions.
Executive – Quality Assurance (Grade II) - UNIMED Technologies Ltd. - Halol, Gujarat
(1999-03 - 2008-08)
cGMP-WHO Certified, SUN Pharma Associated (9+ Years).
- Managed comprehensive QMS operations: change control, deviations, OOS investigations, incidents, and CAPA with supporting data—across SUN Pharma-associated facility.
- Prepared and reviewed master regulatory documents: VMP, Project Validation Plan (PVP), Quality Manual, SMF, SOPs, BMRs, specifications, analytical methods, protocols, and reports.
- Handled market complaint send-to-end; implemented CAPAs with measurable corrective outcomes.
- Conducted cGMP training programs, self-inspections, and vendor qualification activities.
- Authored Quality Risk Management (QRM) documents for drugs and equipment.
- Supported IPQA operations and led project QA work for to new facility builds.
Chemist – Quality Assurance - Elysium Pharmaceuticals Ltd. - Vadodara, Gujarat
(1997-02 - 1999-03)
cGMP-WHO Certified (26 Months).
- Issued BMR/BPR to Production Department and verified IPQA procedure adherence.
- Collected control samples from each batch during packing; reviewed completed BMR/BPR for regulatory compliance.
Chemist – Quality Control - Deepak Nitrite Ltd. - Vadodara, Gujarat
(1995-12 - 1996-12)
API Manufacturing (13 Months).
- Performed analysis of intermediate and finished product API samples per QC procedures, contributing to 100% defect reduction in product release.
