Srikanth Maloth

Assistant Manager @Daicel Chiral Technologies

Hyderabad, IN

Preparing New SOP’s User management, Backup and restoration, Procedure of IT security policies.• Involving QMS Activities (Change control, Deviation Management, CAPA)• Preparation, review, and execution of qualification documents as per 21CFR Part 11 and GAMP5 guidelines.(Validation Master Plan (VMP), User requirements specification (URS), Design qualification (DQ), Risk assessment (RA), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ).• Handling of Computer System Validation.• Successfully completed USFDA audit in 2023 with ‘0’ observation.• Experience in reviewing all SDLC documents, protocols and SOPS to ensure they meet GxP and FDA regulations.• Experience in Developing and reviewing User Requirement Specification URS, Functional Requirements Specification FRS, and Requirement Traceability Matrix RTM Documents• Good Experience GAP analysis and documenting Remediation plan• Excellent Knowledge and experience in good documentation Practice

Jawaharlal Nehru Technological University

Bachelor of Technology - BTech