Kiran Kumar

Seeking a challenging career opportunity where my knowledge and skills in Project, Management, Digital Transformation, CSV, Software Development Life Cycle and hands on experience in relevant tools and techniques to contribute to organizational and personal growth.

Technical CSV Officer at Adcock Ingram Limited (2026-04 – Present)

• eLog Implementation & Documentation: Led eLog implementation activities including BPR/BMR preparation, annexure creation, and documentation management for GMP-regulated manufacturing processes.
• IPQA & Validation Coordination: Performed IPQA activities, coordinated equipment mapping schedules, and supported CSV compliance, data integrity, QA documentation, and cross-functional validation activities.

GMP & Quality Operations Executive at Biocon Biologics Limited (2025-02 – 2025-11)

• System Implementation & Customization: Configure and customized Revvity ELN workflow templates, intigration third party application for upstream and downstream.
• Computer System Validation (CSV): Supported end to end CSV deliverables including IQ, OQ, PQ Change controls, GAP assessment, mitigation plan, deviations & CAPA ensured compliance with 21 CFR Part 11, GAMP5, and EU Annex 11.

Internship at Aurigene oncology LTD (2025-02 – 2025-11)

• Quality Management System (QMS): Reviewed study plans, validation reports, and standard operating procedures (SOPs) to ensure compliance with regulatory standards and project requirements

B. Tech in Biotechnology – Adhiyamaan College of Engineering (2021 – 2025)