Indra Sen

About 13 years of experience in Pharmaceutical Industry as role of Quality analyst, reviewer, planner, Software validation, 21 CFR Part-11 Validation, Change Control Management and implementation of Quality control software. Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations. Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables per 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries. Working knowledge of GLP, GCP, GMP, GAMP V guidelines especially in the areas of computer or related systems. Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report. Experience in Developing and reviewing User Requirement Specifications URS, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents. Good experience in Gap Analysis of software audit.

• Listening music
• Reading books

• Performed Sampling and testing of finished products using current pharmacopoeias or internal specifications, associated with 'wet' chemistry and instrumental techniques (HPLC, IR, UV, GC etc.), as appropriate.
• Handled of instrumental analysis independently like analysis on HPLC (Chromeleon software 6.8 and 7.2 version)
• Calibrate HPLC, UV, IR as per procedure
• Performed Qualification of Laboratory Instrument / Equipment independently.

• Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.
• Authored, reviewed and approved CSV deliverables Validation Project Plan, URS, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report.
• Routed computerized systems documents Validation Project Plan, URS, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report using SAP and eDOCs for review and approval.
• Co-ordinated with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems, system suitability tests, and resolving technical issues.
• Assessed risk related to the systems and analyse them, if necessary, with the Team.
• Directly work with QA for implementing new and upgrading previously validated systems.
• Validated systems used for GMP and Non-GMP purpose.
• Reviewed and followed SOPs to help the business process in line with FDA regulations.
• Organized and attended meeting to discuss the status of the projects.
• Evaluate new software and implement at site.