Geetartha Hazarika

18+ years of experience in GxP Compliance, Computer System Validation (CSV/CSA), and Regulatory Quality Assurance across Life Sciences, Pharma, and Healthcare domains. Proven track record of leading enterprise-wide quality programs, ensuring compliance with US FDA 21 CFR Part 11, EU Annex 11, ISO 9001, and GxP regulations, and driving audit readiness for global regulatory inspections. Expert in building and governing Quality Management Systems (QMS), leading cross-functional teams, and implementing risk-based validation strategies across LIMS and regulated platforms.

Recognized for stakeholder leadership, regulatory risk mitigation, and driving inspection-ready organizations.

Program Manager – Quality & GxP Compliance - Capgemini

(2025-11)

Leading GxP Compliance and Quality Assurance for Life Sciences and Healthcare platforms, acting as GxP SPOC for validation and regulatory alignment.

• Driving risk-based Computer System Validation (CSV/CSA) across system lifecycle (validation → release → decommissioning)
• Governing data integrity, audit trails, access control, deviation & CAPA processes
• Partnering with senior client stakeholders to ensure regulatory compliance aligned with business priorities
• Establishing standardized validation frameworks and compliance practices across programs
• Leading inspection readiness and audit support initiatives. Drive Agentic AI proposals on QMS including Deviation Management, GMP and Audit Support.

Senior QA & Compliance Lead - Abbott Healthcare Pvt. Ltd.

(2018-02 - 2025-11)

Led enterprise-level GxP compliance and validation programs across regulated systems.

• Owned Change Management & Change Control governance for GxP systems
• Ensured compliance with US FDA 21 CFR Part 11, EU MDR, and global regulatory standards
• Directed audit readiness programs, including preparation, coordination, and regulatory inspections support
• Reviewed and approved validation lifecycle documentation (URS, IQ/OQ/PQ, UAT, Validation Reports). Release Management, Requirements Assessment, Protocol and Defect Management using HP ALM tool.
• Implemented risk-based validation strategies, improving efficiency and compliance outcomes
• Led cross-functional teams (IT, QA, Business) to align compliance with delivery timelines
• Strengthened QMS frameworks, SOP governance, and documentation control systems

Associate Principal – QA & Compliance - FORESIGHT Group International AG (now IQVIA)

(2017-02 - 2018-02)

Led end-to-end CSV, Change Management and compliance programs for global pharma clients.

• Ensured adherence to FDA regulations and corporate QMS standards
• Guided teams on GxP compliance, validation lifecycle, and pharmacovigilance (GVP) processes
• Managed project delivery with compliance governance and risk oversight

Senior QA Engineer - Pyramid Consulting Inc.

(2015-02 - 2017-01)

• Delivered QA and validation for pharma applications
• Managed test strategy, validation documentation, and release compliance
• Collaborated with stakeholders on requirements traceability and defect management

QA Engineer (CSV Specialist) - LABVANTAGE Solutions

(2008-04 - 2015-01)

Specialized in LIMS validation and FDA 21 CFR Part 11 compliance.

• Delivered validation documentation, CAPA compliance, and lifecycle testing. Supported regulated workflows including sample lifecycle, batch management, and biobanking

Bachelor of Technology - Electronics and Communication - International Institute of Information Technology, Kolkata (West Bengal) (2004 - 2008)

12th - PCM - Salt Brook Academy, Dibrugarh (Assam) (2001 - 2003)

10th / High School - Don Bosco School, Dibrugarh (Assam) (1989 - 2000)