Jaideep Goyal
Senior Validation Specialist || GMP Professional || IT & Engineering Compliance || Commissioning || Qualification || Validation || Quality Assurance || CSV || QMS
- Role
- Site Validation Lead at Reliance Life Sciences Pvt. Ltd
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Jaideep Goyal
As a seasoned CQV (Commissioning, Qualification & Validation) professional with over 15+…
Experience
Site Validation Lead
Reliance Life Sciences Pvt. Ltd
Jan 2024 — Present · 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).
Education
Noida International University
Master of Technology (M.Tech.), Biotechnology
Amity University
B.Tech (Biotechnology), Biotechnology
Amity University
Bachelor of Technology - BTech, Biotechnology
Skills
- Cleaning Validation
- Glp
- Quality Assurance
- Capa
- Quality System
- V&V
- Regulatory Requirements
- Oos
- Verification and Validation (V&V)
- Change Control
- Hplc
- Sop
- Fda
- Good Laboratory Practice (Glp)
- Corrective and Preventive Action (Capa)
- Equipment Qualification
- Quality Auditing
- High-Performance Liquid Chromatography (Hplc)
- Mhra
- Validation
- Gmp
- Regulatory Affairs
- Deviations
- Regulatory Submissions
- Anda
- Lyophilization
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
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