Samir Shah

Results-driven Head Quality Assurance professional with 29+ years of specialized experience in sterile Injectable and oral solid dosage pharmaceutical manufacturing. Proven record of successfully clearing WHO, USFDA, MHRA, TGA, EU GMP/PIC'S, and international regulatory audits across five certified organisations — with zero critical observations in recent audits. Deep expertise in cGMP compliance, Site Master File (SMF), Validation Master Plan (VMP), SOP development, CAPA management, Computer System Validation (CSV), and ERP implementation (PharmaCloud).

Consistently led facility startups, QA team building, and quality system transformations resulting in measurable improvements in product quality, audit readiness, and regulatory compliance.

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.

Bachelor of Science - Special Chemistry - Dabhoi Nagarpalika Arts & Science College (1993 - 1995)

Primary & Secondary High School - Science - Dayaram Sharda Mandir High School (1989 - 1991)