Sneha C.
Validation Engineer at Amneal Pharmaceuticals
- Role
- Validation Engineer at Amneal Pharmaceuticals
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Sneha C.
I have completed my Masters in Pharmaceutical Manufacturing from Stevens Institute of…
Experience
Validation Engineer
Apr 2015 — Present · New York, NY, US
Subject matter expertise (Qualification of Equipment, Facility, Utility Validation) • Generate/Execute/Review validation protocols (IQ/OQ/PQ/DQ) for the pharmaceutical equipments for Mixing, Compression, Packaging, Softgel, Pharmacy, Coating and Laboratory to meet cGMP and FDA regulations and guidelines.• PLC, Software and Optel Vision System Qualification. • Perform SAT (Site Acceptance Test), FAT (Factory Acceptance Test) for the pharmaceutical equipments. • Generate/Execute/Review Validation Protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facility (Production rooms, Warehouse, QA Sampling Rooms.) and utility qualification (Compressed Air system, HVAC system, Humidity control system, Dust collection system, Vacuum system, Purified (De-ionized) water system)• Develop and maintain the Validation Master Plan and the Calibration Schedule. • Develop the Preventive Maintenance Program Schedule for equipments, utilities and prepare the Standard Operating Procedures (SOPs)• Lead, support and coordinate with the vendors/contractors for the installation of new equipment, engineering project execution and meeting deadlines.• Raise Change Control to make any changes/modify the existing procedure/equipment or introduction of new method/equipment in the system. • Perform/Investigate Discrepancy Reports, FMEAs and Root Cause analysis.• Coordinating with QA and compliance team for generating CAPAs for equipments and process failure.• Recordkeeping, sanitization and maintenance of Purified (De-ionized) Water System• Assess revalidation requirements to ensure continuous compliance of regulatory requirements• Assist with investigations and FDA inspections.Selected Contributions• Established a preventive maintenance schedule, ensuring optimal equipment operation without costly downtime.• Significantly reduced waste and end-to-end production time by levering expertise with Statistical Process control (SPC) methodology.
Education
Stevens Institute of Technology
Masters, Pharmaceutical Manufacturing
2013 — 2014
Rofel Shri G.M. Bilakhia College of Pharmacy
Bachelors, Pharmacy
2008 — 2012
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