Experience

SPARKVEE FINE CHEMICALS PRIVATE LIMITED
• India
• Chemical Manufacturing
• 1 - 100 Employee
• R&D Manager

  • Jun 2020 - Present

BOMBAY DRUG HOUSE
• Quality Assurance Intern

  • Nov 2019 - Jun 2020


Celgene

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Consultant

  • Dec 2018 - Jul 2019

  • Authored deviation reports, CAPAs, NCRs• Carried out investigations for deviations caused during processing of CAR T cell • Well versed with quality management systems like eQRMS and electronic document management systems like CelDox.• Authored standard operating procedures for equipment like water bath, centrifuges, refrigerators, freezers, plasma extractor • Prepared Validation Master Plan Validation Protocol, and Final report in compliance with 21 CFR guidelines, ISO and FDA regulatory specifications.• Ensured complete 21CFR part 11 compliance assessments for manufacturing systems.• Create and update Batch Records, SOP and assist in other management deliverables. Show less

• Consultant

  • Feb 2018 - Nov 2018

  • Authored non-validation protocols, Validation summary reports, and standard operating procedures.• Worked closely with team to plan the startup readiness of CAR T cell manufacturing plant using SIPOC diagrams.• Writing and formatting Quality control documents like bulk gas handling, Sample management, Test methods and Specifications.• Created cross functional flowcharts, Basic flowcharts and fishbone diagrams Visio. • Gathered requirements and Authored manufacturing documents pertaining to waste handling procedure in suites, movement of samples and reagents in process suites.• Worked closely with manufacturing and quality control team to perform root cause analysis for product specifications. Involved in making fishbone diagrams.• Authored and formatted standard operating procedures for equipment like particle analyzer, water purifier, cell processor, incubators, centrifuges, water baths etc.• Gathered requirements and authored facility documents like contamination control, environmental monitoring for production areas.• Authored and formatted validation summary reports for centrifuges, refrigerators, freezers, and incubators. Show less



Ipca Laboratories Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Intern

  • May 2013 - Jul 2013

  • Synthesized API 4-chloro 3-nitro anisole for production of Iguratimode medicine used for arthritis. • Hands-on lab experience in NMR, HPLC, and Thin-layer chromatography. • Planned and evaluated results of analysis, modeling, and experiments. • Promoted and implemented process improvements. • Designed and performed complex experiments. • Conducted research that tests and analyzes the feasibility, operation, and performance of experiments. • I am also skilled in handling lab processes and batch manufacturing. Show less

• Trainee engineer

  • 2012 - 2013

  • Involved in generation & execution of IQ, OQ, PQ protocols for manufacturing processes/equipment. • Responsible of preparing and executing protocols (USR, FSR, IQ/OQ, PQ and Final Reports). • Revised and evaluated any discrepancies found/issued during validation activities for HVAC Systems, Process Equipment, and Utilities. • Performed P&ID walk downs for the Installed Equipment's and Instrumentation. • Prepared Validation Master Plan Validation Protocol, and Final report in compliance with 21 CFR guidelines, ISO and FDA regulatory specifications. • Ensure that the site Validation Master Plan remains current and aligned with corporate policies and industry standards/expectations. • Reviewed and approved changes to critical processes, facilities, equipment, and systems through the change control program to assess impact on validated systems. • Ensured complete 21CFR part 11 compliance assessments for manufacturing systems. • Authored validation/re-validation protocols, process Verification and coordinate execution, perform, and summarize qualification and validation activities. • Developed work-flow charts and diagrams to ensure production team compliance with client deadlines. • Execute Temperature Mapping Studies, Control check and Qualifications for Autoclaves, Bioreactors, clean room with kaye validator. • Create and update Batch Records, SOP and assist in other management deliverables. • I have worked on identifying process/protocol related issues to increase the process productivity. Show less