ABHIJIT SARMA

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.

• Skilled in Risk assessment, 21 CFR part 11, and GAMP 5 guideline documentation
• Strong focus on Computer System Validation, software quality assurance, and FDA regulations expertise
• Proficient in conducting security assessments and documenting validation protocols
• Managed diverse automation and process systems (DCS, PLC, HMI/SCADA, etc.) for unit operations, showcasing comprehensive expertise in the field
• Proficient in documenting User Requirement Specifications (URS), Design Specifications (DS), and Installation and Operational Qualification (IQ/OQ) documents
• Through understanding of Software development life cycle (SDLC)
• Managed IT quality processes including deviation management and CAPA implementation
• To perform data backup/archival/retrieval/restoration on need basis

• Executing admin support for manufacturing related issues in SCADA/HMI/PLC based systems or GxP applications
• Represent IT into any regulatory, Customer or internal Inspection at site level
• Ensure adherence to organizations/site/department (IT) policies (SOP's), guidelines, procedures and ensure generations of adequate and accurate documentation to cope up with regulatory guidelines
• Preparation of monthly project review slides and participation in periodic activities on need basis
• Taking active part in CSV with collaboration with CSV team and reviewing the same after execution
• To intimate system owners/technical owners to mitigate gap through CCR/CAPA