Sanjay Harod
CSV Validation,Equipment Qualification,Cleaning Validation and Audit & Quality compliance at Lupin
- Role
- Validation and Qualification at Lupin
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About Sanjay Harod
About 10+ year of rich industrial (Pharmaceutical) work experience in Quality department. Understanding of regulatory requirements and expectations. Successfully faced USFDA and MHRA inspections.Expert in various Validation and Qualification aspects- Handling of project as a lead of the various dosage forms like Tablet, ointment, DPI, MDI, DERMA and NASAL- Prepare and maintain projects plan and tracking the activities to closure on timely basis- Communicating with OEMs to explain requirements necessary for successful implementation of the project- To review CSV documents GxPA and Non GxPA categorization URS, VPP,EDC,FRS,FRA,DCS,VP,IQ,OQ,PQ, SRC and VSR with TM- To prepare site master file and Validation Master Plan.To prepare and review FMECA fir Product, facility and equipment-TO prepare and review Validation planner, calibration and PM- To review layout of Facility, equipment and utilities- Initiation, review, logging, impact assessment and approval of change control, deviation and CAPA- To prepare and review URS, DQ,FAT, SAT, IQ,OQ and PQ of HVAC, Equipment and Facility Qualification- To participate in Facility, Equipment Qualification and Requalification- To prepare and review cleaning Validation, process Validation protocol and reports- Preparation of cleaning Validation matrix and establishments of worst case products- Acceptance criteria calculation and execution of cleaning Validation activity- Preparation of sampling plan for rinse and swab sampling- To execute the cleaning Validation activity, process Validation batch and exhibit batces- To prepare and execute cleaned equipment hold time study, Dirty equipment hold time and campaign study- To participate in Temperature mapping study- To participate and review compressed air and nitrogen Validation activity.
Experience
Validation and Qualification
May 2020 — Present · Indore, IN
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
master of pharmacy, Pharmacy
2010 — 2012
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