Sahil Dhengle
Executive L2 | Quality Assurance Operation| Bharat biotech international limited, Hyderabad |
- Role
- Executive Level 2 at Bharat Biotech
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sahil Dhengle
Conduct line clearance and real-time batch monitoring for various vaccine drug substances manufactured under development, cinical trial, and GMP stages.Ensure full GMP compliance during manufacturing and testing of development, dinical trial, and GMP batches.Prepare and review SOPs, media fil protocols, cleaning validation protocols, and process validation protocolls.Coordinate with cross-functional R&D teams to identify material requirements for cell bank activities, R&D lots, GMP lots, and related activities.Draft SOPs and perform detailed review of critical documents, including Master Formule Records (MFR), Batch Manufacturing Records (BMR) process validation reports, aseptic process simulation (media protocole/reports, scientific rationales, justifications, development reports, and logbooks.Support preparation and submission of regulatory dossiers to ensure timely filing and complete regulatory compliance,Review executed Batch Production Records (BPR), testing reports, Certificates of Analysis (CoA), and Environmental Monitoring Program (EMP) data for development betches.Manage the Ifecycle of change controla, deviations, CAPAS, Out of Specification (ODS), Out of Trend (ODT), Quality Risk Assessments (QRA), and Out of Limit (OOL) investigations including follow-up, root cause analysis, and timely closure,
Experience
Executive Level 2
Jan 2026 — Present · Hyderabad, IN
Education
Shri Chhatrapati Sambhaji Shikshan Sansthas Sitabai Thite College of Pharmacy, Shirur, Ghodnadi, Dist . Pune 412210
Bachelor of Pharmacy
NIPER Hajipur
M.S. in Pharmacology and toxicology
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