Gourav Gaonkar

Product Manager

Goa, India15 yrs 4 mos experience

Highly StableAI Enabled

Key Highlights

15+ years of experience in pharmaceutical quality systems.
Expert in Computerized System Validation and digital transformation.
Led successful enterprise-wide software implementations.

Stackforce AI infers this person is a Pharmaceutical Quality Assurance expert with a focus on digital transformation and compliance.

Contact

Skills

Core Skills

Computerized System Validation (csv)Project ManagementIt Service ManagementRegulatory ComplianceVendor Qualification And Supplier AuditsGxp AuditsQuality Management System

Other Skills

LIMS & DMS ValidationChange Control ManagementProject Management (Pharma IT & QA)cGMP ComplianceCAPA ManagementSAP S/4 HANA QualificationU.S. Title 21 CFR Part 11 RegulationGAMP5Quality Management System (QMS)Corporate Training & LeadershipData Integrity ComplianceTrackWise ImplementationEU Annex 11ISO 27001GxP Compliance

About

I help pharmaceutical organizations implement and validate digital quality systems in regulated environments. With 15+ years of experience across industry and consulting, I specialize in Computerized System Validation (CSV/CSA), Veeva Vault implementations, TrackWise QMS, SAP S/4 validation and audit readiness aligned with GAMP5, 21 CFR Part 11 and EU Annex 11. Currently working with global clients on digital quality transformation initiatives including system implementation, risk-based validation strategies, vendor qualification and inspection preparedness. My focus is bridging Quality, IT and Business teams to ensure compliant system adoption rather than just documentation compliance.

Experience

15 yrs 4 mos

Total Experience

2 yrs 7 mos

Average Tenure

2 yrs 4 mos

Current Experience

Ey

2 roles

Manager

Promoted

Sep 2024 – Present · 1 yr 8 mos · Mumbai, Maharashtra, India · On-site

Lead CSV, equipment qualification, and GxP compliance projects across pharma clients, ensuring full alignment with 21 CFR Part 11, EU Annex 11, and GAMP 5.
Successfully managed SAP S/4 HANA qualification, including configuration, testing, and validation.
Conducted gap assessments of validation dossiers, reducing regulatory risks and enhancing inspection readiness.
Delivered 50+ training programs on CSV, CSA, and Data Integrity for cross-functional teams.
Performed global GxP vendor audits (API, raw/packaging materials) ensuring adherence to quality standards.
Designed and implemented an IT security audit checklist tailored for the pharmaceutical industry, conducting detailed compliance assessments and ensuring adherence to ISO 27001 standards.
Conducted assessments of clients’ IT application portfolios and collaborated with stakeholders to design future-ready IT strategy roadmaps supporting operational efficiency and compliance.
Impact: Strengthened client compliance posture, resulting in fewer audit findings and improved regulatory alignment.

LIMS & DMS ValidationVendor Qualification and Supplier AuditsChange Control ManagementProject Management (Pharma IT & QA)cGMP ComplianceCAPA Management+13

Senior Consultant

Jan 2024 – Sep 2024 · 8 mos · Mumbai, Maharashtra, India · On-site

Vendor Qualification and Supplier AuditsSupplier ManagementSupplier AuditsSoftware Project ManagementSoftware Development Life Cycle (SDLC)GxP Audits

Indoco remedies ltd.

3 roles

Deputy Manager

Apr 2023 – Jan 2024 · 9 mos · Goa, India · On-site

CSV Lead for implementation of enterprise systems – TrackWise, LMS, DMS, SAP S/4 HANA, LIMS.
Directed end-to-end CSV lifecycle including URS, FRS, OQ, PQ, traceability, and validation summary reporting.
Conducted vendor audits for raw materials and packaging vendors, ensuring supplier quality compliance.
Managed cross-functional teams, achieving seamless digital QMS transformation across multiple sites.
Impact: Drove successful enterprise-wide software implementations, enabling improved QMS efficiency and global regulatory compliance.

cGMP manufacturingQuality Management SystemProject ManagementTrainingTeam LeadershipComputer Software Assurance+13

Assistant Manager

Promoted

May 2021 – May 2023 · 2 yrs · Goa, India · On-site

CSV Lead for implementation of enterprise systems – TrackWise, LMS, DMS, SAP S/4 HANA, LIMS.
Directed end-to-end CSV lifecycle including URS, FRS, OQ, PQ, traceability, and validation summary reporting.
Conducted vendor audits for raw materials and packaging vendors, ensuring supplier quality compliance.
Managed cross-functional teams, achieving seamless digital QMS transformation across multiple sites.
Impact: Drove successful enterprise-wide software implementations, enabling improved QMS efficiency and global regulatory compliance.

cGMP manufacturingQuality Management SystemProject ManagementTrainingTrackWiseVendor Qualification and Supplier Audits+12

Senior Executive

Dec 2019 – May 2021 · 1 yr 5 mos · Goa, India · On-site

cGMP manufacturingQuality Management SystemTrainingTrackWiseVendor Qualification and Supplier AuditsRegulatory Compliance+4

Teva pharmaceuticals

Executive

Jul 2016 – Dec 2019 · 3 yrs 5 mos · Goa, India · On-site

Managed Change Control process and acted as TrackWise coordinator for the site.
Conducted vendor qualifications and maintained Quality Technical Agreements with suppliers.
Coordinated with global stakeholders (Japan, Canada, EU) for compliance approvals.

cGMP manufacturingQuality Management SystemTrainingTrackWiseVendor Qualification and Supplier AuditsQuality Technical Agreement+5

Encube ethicals private limited

Regulatory Affairs Officer

Nov 2014 – Jul 2016 · 1 yr 8 mos · Goa, India

Conducted 50+ vendor audits (API, excipients, packaging).
Designed and implemented audit schedules, compliance reports, and corrective actions.
Supported QMS functions: change control, deviations, CAPA management.

cGMP manufacturingDMF UPDATEQuality Management SystemTrainingTrackWiseVendor Qualification and Supplier Audits+6

Abbott

QA Officer

Apr 2013 – Nov 2014 · 1 yr 7 mos · Verna Goa · On-site

Lead Auditor for vendor audits (20+ on-site audits for API, excipients, and packaging vendors), including for-cause audits to resolve compliance risks.
Managed Quality Management System (QMS) processes, including change control, deviations, CAPA management, and audit schedules.
Reviewed executed and master batch manufacturing records to ensure GMP compliance.
Participated in process validation activities for Oral Solid Dosage (OSD) forms, including area and AHU validation with external vendors.
Oversaw creation of material masters in SAP to ensure data integrity and regulatory alignment.
Drafted, reviewed, and maintained Quality Technical Agreements and vendor documentation (TSE/BSE, residual solvents, phthalates, benzophenone, etc.).
Impact: Strengthened supplier quality standards, streamlined QMS processes, and supported regulatory inspections with robust vendor qualification programs.

cGMP manufacturingTrainingVendor auditsVendor Qualification and Supplier AuditsVendor ManagementRegulatory Compliance+7