Srikanth Maloth
CSV |GxP|eCompliance | QMS| GAMP5 | Risk Assessment | Data Integrity| 21 CFR PART 11 | Annexure 11 | Supplier Assessment/Audit| Internal Audits
- Role
- Assistant Manager at Daicel Chiral Technologies
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Srikanth Maloth
Over 12 years of experience in pharmaceutical, Biotech, Drug and device…
Experience
Assistant Manager
Dec 2022 — Present · 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
Education
Jawaharlal Nehru Technological University
Bachelor of Technology - BTech
Skills
- Microsoft Excel
- Outlook
- Microsoft Word
- English
- Core Java
- Html
- Windows
- Wireless Networking
- Networking
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