Shubham Nila

Experience

• 

  Johnson & Johnson

  Apr 2018 - Oct 2019

  QA Officer

  Core team member of INDIA LIMS implementation.with following responsibilities: Creation of User and Functional Requirements :Understand Pharmaceutical SOP and Process. Good knowledge in all modules of Labware LIMS, Label Printer, Environment Monitoring, Storage Location Management, Instrument Interfaces, Lot, Sample Management, Labware LIMS v6 module. Configuration of Master Data for two sites in INDIA Test Script creation & CSV (Computer System Validation).  Performing UAT (User Acceptance Test) Operational Qualification. Performance Qualification End users Training. Show less

• 

  EY

  Oct 2019 - Jun 2022

   Complete Computer System Validation, ERP validation, LIMS Application. Performing Internal ERES Audit of computer system validation projects as per USFDA’s 21 CFR Part 11 and EU’s guidelines Annex 11 Audit observation reporting with implications, Recommendations and Mitigation plan Handling QMS : change control process, CAPA, deviation and SOP preparation for Pharmaceutical industry. Implementing modules like Lot Management, Stability, Inventory Management, Investigation Management and validating the modules implemented. Preparation and review of validation lifecycle documents like validation plan, GxP Assessment, risk assessments, Requirement specifications, OQ/PQ Protocol, OQ/PQ Report, Requirement traceability, Validation summary report Show less

  • CSV Consultant

    Jul 2021 - Jun 2022

  • Associate Consultant

    Oct 2019 - Jul 2021
• 

  PwC

  Feb 2022 - now

  • Manager

    Apr 2024 - now

  • Senior Consultant

    Feb 2022 - May 2024