T Ramesh Email & Phone Number

• Over 13 years of experience in pharmaceutical and biotechnology environments with all category Computerized Systems Validation as per GAMP 5 guidelines. • Good exposure on SDLC & STLC documentation and responsible for tracking, monitoring and controlling validation process to ensure timely and cost-effective delivery of the system to the business users /customers as per cGMP (21 CFR Part 210-211), EU cGMP (Eudralex Volume 4 and Annexes), GxP Guidelines, 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity Principles, GAMP 5 and main FDA Guidance(s) for industry.• Responsible for Prepare, review and approval of all levels of CSV validation documents including:Validation Plans, User Requirement Specifications, validation strategy, IQ, OQ, PQ, RTM, ER/ES/AT.• Review and approval of High-Level risk-based approach GxP Assessment and GAMP categorization, criticality Assessment, ERES Applicability Assessment etc. • Definition Documents, including Functional Specifications, Design Specifications or Configuration Documents and SOPs, VMP and VP. • Review and Approval Qualification Documents and Test Specifications (DQ, IQ, OQ scripts) • Traceability Matrices, Gap assessments and Risk Analysis • 21 CFR Part 11, EU annex 11 assessments for Process systems • Well knowledge in IT quality compliance as per regulatory requirement.• Provide CSV technical sign-off for all the above • Experience in various Software Development Life Cycle (SDLC), Like Waterfall, V-Model, and Agile methodology.• Expertise in documenting Design Review and Qualification Protocol, Technical Writing. Excellent experience as Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). • Providing the guidance/support to internal teams for external/Regulatory Audit preparation/Audit compliance.• Experienced in Periodic review to confirm that the computerized system remains in a valid state and are compliant with regulatory and standard requirements.• SME of Defect/Deviation management and CAPA Management.• Prepare and Review Data Migration Plan, System Retirement Plan with their summary Report.• Experienced in validation tools Valgenesis, Validator.• Interact with business & the clients to understand and gather business requirements; pro-actively propose solutions on CSV projects that will add value to the company. • Provide training on Computerized System Policies, SOPS, industry regulations trends and “hot topics” to project team members, system owners and users.