B Srinivasu
Certified CSV - Specialist | GxP Assessment | CSV Assessment as per GAMP 5 & EU Annex - 11complaince requirements, Risk-based approach | Data Integrity Compliance as per 21CFR Part 11 regulatory requirement.
- Role
- Senior Manager - Cqa at Eugia Pharma Specialities Ltd
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About B Srinivasu
A result-oriented, certified CSV specialist with 9 years of experience in computer system validation. Expertise in the implementation of system validation as per the Software Development Life Cycle (SDLC) and compliance with EU Annex 11 guidelines, a science and risk-based approach as per GAMP 5 guidelines, and FDA 21 CFR regulations. Hands-on experience in key validation deliverables (IRA/HLRA/GxP Assessment, Functional Risk Assessment, Supplier Assessment, URS, Validation Protocol, Functional Specification/Functional Requirement Specification, Configuration Specification, Design Specification, IQ, OQ, PQ, Report Traceability Matrix, and Validation Summary Report) as per the system categories. Expertise in testing as per the Software Testing Life Cycle (STLC), as per compliance with GAMP-5 guidelines, by using different software methodologies like waterfall, spiral, V-model, and agile Expertise in the implementation of operational phases like security management (electronic records and electronic signatures) as per FDA 21 CFR Part 11 regulatory requirements; data backup; periodic verification; restoration; and disaster recovery as per 3-2-1-1-0 backup rule requirements; incident, deviation, and change management as per ISO and ICH Q10; business continuity plan for the system downtime; and periodic review and revalidation as per the internal schedule. Experience in system retirement/decommissioning phase (planning, data management, and reporting). Expertise in the verification of data integrity requirements as per the FDA 21 CFR Part 11, 210, 211, and MHRA data integrity regulations. Expertise in GAP assessment and Risk Assessment (Qualitative and Quantitative methodologies) as per the ICH Q9 guidelines.
Experience
Senior Manager - Cqa
Sep 2024 — Present · Hyderabad, IN
Education
Periyar University
Master of Science (M.Sc)
2002 — 2004
Osmania University
Bachelor of Science (B.Sc)
1998 — 2001
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