Jaideep Goyal

Site Validation Lead @Reliance Life Sciences Pvt. Ltd

Navi Mumbai, IN

Spearheaded end-to-end CQV for GMP facilities (HVAC, clean utilities, process equipment & and computerized systems), ensuring compliance with FDA/EMA. Implemented corporate validation policies, harmonizing activities across site and reducing audit findings by 40%. Led engineering assurance for facility design, reducing project delays by 25% via proactive risk assessments. Managed regulatory audits (including client and FDA), resolving 100% of observations within 30 days. Provide Engineering Assurance oversight to ensure that facility and equipment designs meet regulatory and project requirements from concept through turnover. Implementation and train personnel for Qualification related software (Validator). Handling regulatory and client audits, support internal audits and ensure internal & external compliance. Providing support in assessing QMS requests and reviewing the risk assessment related to validation activities. Coordinating with cross functional leads on critical project forecasts and proactive planning for resource mapping. Investigation, review, approval of IT and engineering related QMS elements (Deviation, Investigation, CAPA & Change Controls).

Noida International University

Master of Technology (M.Tech.), Biotechnology

Amity University

B.Tech (Biotechnology), Biotechnology

Amity University

Bachelor of Technology - BTech, Biotechnology