Anteek Bhattacharya
Mumbai
Summary
Results-driven, detail-oriented IT QA professional with 4.5 years of experience across pharmaceutical and product-based environments, supporting Computer System Validation (CSV), Quality Management Systems (QMS), GMP/GxP-regulated systems, and information security governance activities. Hands-on experience across R&D and Engineering in maintaining compliant, well-documented, audit-ready systems aligned with global regulatory and security standards. Proven contributor to Indian and US FDA inspections, with recent exposure to ISO 27001 and SOC 2 compliance support, risk and control assessments, and cross-functional collaboration.
Overview
5
5
years of professional experience
Work History
Assistant Manager, Compliance and Process ,
Velox Solutions
Navi Mumbai
01.2026 - Current
- Supporting ISO 27001 and SOC 2 compliance activities, including control mapping, evidence collation, and audit readiness support
- Assisting with risk and control assessments, remediation tracking, and maintenance of compliance artifacts
- Contributing to vendor security reviews, governance documentation, and privacy-related controls under senior guidance
- Supporting policy and procedure updates, including information security and privacy-related documents
- Assisting with internal compliance tracking, such as maintaining evidence repositories, control registers, and follow-up items
Sr. Associate, IT QA (R&D & Engineering) ,
Endo India (PAR Formulations)
Navi Mumbai
06.2021 - 12.2025
- Led IT QA activities for GMP/GxP systems across R&D and Engineering, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5
- Executed and reviewed the complete Computer System Validation (CSV) lifecycle, including URS, risk assessments, IQ/OQ/PQ, validation protocols, reports, and traceability matrices
- Managed QMS processes including deviations, CAPA, change control, and periodic reviews, ensuring accurate documentation and timely QA approvals
- Supported US FDA and Indian FDA inspections, contributing to zero major observations across IT QA, CSV, and data integrity areas
- Maintained validated state and data integrity for systems such as Empower, Veeva Vault, and TrackWise, including audit trail reviews, access control management, backup verification, restore testing, IT infrastructure support, Active Directory, service desk operations, incident management, and coordination with global IT teams
Education
B.Tech. - Electrical And Electronics Engineering
SRM University
Chennai06-2020
Skills
- ISO 27001 compliance
- Computer system validation (CSV)
- Information Security Governance
- Quality management systems
- GMP compliance
- Data integrity management
- Audit & Compliance Support
- Trackwise
- MS office
- System Life Cycle (URS/IQ/OQ/PQ)
- FDA & US-FDA Audit Experience
- 21 CFR Part 11
- Stakeholder Coordination
Accomplishments
Above & Beyond Award (Endo) - Played a key role in Indian & US FDA audits with zero major observations for IT QA Scope
Timeline
Assistant Manager, Compliance and Process ,
Velox Solutions
01.2026 - Current
Sr. Associate, IT QA (R&D & Engineering) ,
Endo India (PAR Formulations)
06.2021 - 12.2025
B.Tech. - Electrical And Electronics Engineering
SRM University