Abhijit Sarma

Experience

• 

  INSTRUMENTATION AND CONTROL SOLUTIONS

  Jan 2022 - Jul 2024

  RESPONSIBILITIES:1. Maintain inventory list of Manufacturing Automated System including PLCs/SCADA systems installed at Site.2. Assist in 21 CFR Part II Assessment during Computerized system selection. 3. Prepare and Maintain IT related SOPs (as applicable) for manufacturing automatedsystems including PLCS/SCADA.4. Perform/participated into qualification and validation of Manufacturing Automated systems including PLCs/SCADA systems from IT for various IT admin roles. 5. Review of qualification and validation documents of Manufacturing Automated systems including PLCs/SCADA system from IT perspective covering 21 CFR Part-11 applicability, ER/ES, User & Role Management, Software Categorization, andAudit trail etc.. 6. Provide IT administrative support on Operating Systems (OS) of Computer Servers. Desktops, Laptops, Industrial PCs, and Handheld devices etc., which are used in Manufacturing Automated Systems including PLCs SCADA systems at Site.7. Application Admin Support for Application Software installed on Computer Systemsused for Manufacturing automated Systems at Site.8. Perform the data and program backup and retrieval of Manufacturing Automated Systems including PLCs/SCADA system as per application SOP(s) at Site. 9. Review and verification of corrective Action plan identified in Manufacturing Automated systems including PLCs/SCADA during internal and external audits.10. Preparation and Execution of IT Manufacturing SOP, Change Control, Deviation and CAPA11. Data export from OT systems and making it available for cross functional user'sprocess related analysis. 12. Initiation of QMS as per IT Operation requirements, investigation, CAPA implementation.13. Preparation of SOPs as per process development requirements for Informationtechnology.14. Participate in internal and external Audits to respond on IT related points for manufacturing Automated Systems including PLCs/SCADA. Show less First level point of contact for Admin support forManufacturing related issues in SCADA/HMI/PLC basedsystems or GxP applications. Represent IT into any regulatory , Customer or internalInspection at site level. Ensure adherence to organisations/site/department(IT)policies(SOP's), guidelines,procedures and ensuregenerations of adequate and accurate documentation tocope up with regulatory guidelines. Preparation of monthly project review slides andparticipation in periodic activities on need basis. Taking active part in CSV with collaboration with CSVteam and reviewing the same after execution. To perform validation and challenge test as defined tomeet regulatory requirement. To perform data backup/archival/retrieval/restoration onneed basis. To intimate system owners/technical owners to mitigategap through CCR/CAPA. Show less

  • Executive IT engineer

    Nov 2021 - Jul 2024

  • Executive Engineering IT service

    Jan 2022 - Feb 2023
• 

  INSTRUMENTATION AND CONTROL SOLUTIONS

  Nov 2024 - now

  Senior Executive

  Experienced IT Compliance Engineer with expertise in GxP, cGMP, and regulatory compliance within the pharmaceutical industry. Skilled in IT asset management, system validation, user access control, and IT compliance tracking. Proficient in backup & archival management, IPC/HMI/PLC systems, SCADA, and enterprise applications. Strong background in investigation reporting, QAMS activities (CAPA, CCP, deviations), self-inspection compliance, and IT SOP development. Adept at IT project rollouts, system monitoring, corrective & preventive actions, and ensuring documentation best practices for GMP/CSV compliance. Passionate about enhancing IT processes, maintaining data integrity, and driving operational efficiency. Show less