Anuj Upadhye

Experience

• 

  Mylan Laboratories Limited

  Aug 2015 - Aug 2018

  •Computer System Validation (CSV), Equipment Qualification/ Validation, SOP Preparation (CARA), Change Control e.t.c.•Preparation, execution and review of all protocols related to Equipment Qualification and computer System Validation-CSV like GAP Assessment, Risk Assessment, IRA, URS, DQ, CS, FS, FRA, VP, IQ, OQ, PQ, TM, VSR e.t.c. as per GAMP 5, 21 CFR Part 11, EU Annex 11, e.t.c.•Project Lead for PLC Validation and User Access Review activity for all production, Warehouse and packaging equipments.•Perform FAT for equipments like Coating machine, compression machine, RMG, FBP e.t.c•Trackwise related activities like Change Control initiation and follow up.•Tracking and updation of all activities related to Equipment Qualification.•Faced several audits like USFDA, MHRA, TGA, Europe, Germany e.t.c.•performed internal audits, report Preparation and verification Show less

  • Engineer, Computer System Validation

    Aug 2015 - Aug 2018

  • Engineer

    Aug 2015 - Aug 2018
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  EY

  Aug 2018 - Jan 2021

  Consultant

  1. Perform assessments of computer systems and equipments for compliance with internal procedures, leading practices, and regulatory requirements.2. Manage IT/CSV projects for various pharmaceutical clients.3. Create Computer System Validation deliverables like Initial Risk Assessment, User Requirements Specifications, Validation Plan, Supplier Assessment, Functional Specification, Functional Risk Assessment, Configuration Specification, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrix, Validation Report and Standard Operating Procedures.4. Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle.5. Review and verify computer system validation protocols, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.6. Perform Internal Audits for various pharmaceutical clients, assess the Gaps and suggest mitigations for compliance.7. Prepare project status reports by collecting, analysing, and summarizing information and trends.8. Co-ordinate with Project Management and Vendors to ensure timely project execution that meets expected quality requirements and specifications.9. Integrate continuous improvement concepts and techniques into all aspects of the job.10. Perform Information Technology General Controls (ITGC) Audits Show less

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  Billennium

  Jan 2021 - now

  • Validation Lead

    May 2023 - now

  • Technical Lead

    Feb 2022 - now

  • Senior Validation Specialist

    Jan 2021 - Jan 2022