Ajinkya Lokhande

Total 3+ years of experience in Computer System Validation (CSV), GAMP 5 guideline, 21 CFR part 11 compliance, EU Annex 11, GxP based software testing, Jira tool, SDLC & STLC, Manual testing.

Computer System

Validation for GxP based systems using GAMP 5 Guideline.

Experience in the SDLC and STLC from requirements gathering to releasing to production. Well versed with knowledge in tools like Jira.

CSV Engineer at Lupin Ltd Pune (LRP) @Payroll of Qforce- A Primus Techsystems company (2024-05 – Present)

Computer System Validation for GxP based systems using GAMP 5 Guideline and V model approach.

• Prepare and review validation documents and related deliverables, such as Risk Assessment, 21 CFR Part 11 Assessment, Validation Plan, User Requirement Specification, Traceability Matrix & Validation Report.
• Ensure documentation and practices meet GDP, applicable regulatory compliance and company guidelines/policies.
• Review the accuracy and completeness of software validation deliverables (IQ,OQ &PQ) test scripts & other deliverables.
• Create 21 CFR part 11 test scripts, review test scripts with various teams.Review test execution results after executing test scripts, monitor test execution and defects.
• Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, EU Annex 11 and GAMP5 guideline.

Jr.Project Engineer at USV Pvt Ltd Navi Mumbai @Payroll of DHA Tekhno Pvt Ltd. (2023-05 – 2024-04)

CSV validation for GxP based systems using GAMP5 guidelines and V-Model approach. Visited Sites: Cipla Ltd Kurkumbh, MSN Labs Hyderabad, USV ltd Ratnagiri, Cadila Pharma Jammu

• CSV validation for GxP based systems using GAMP5 guidelines and V-Model approach. Authoring and reviewing validation deliverables (GxP Assessment, URS,VP, FRS,DCS, FRA, IQ/OQ/PQ, RTM, VSR, SRC etc.)
• R&D Software Validation(Chromeleon 7.3.1, BMS,EMS)
• 21CFRPart11AssessmentofcontrolSystemand software.
• Validating computer system, preparation and reviewing validation deliverables as per validation protocol for SCADA/PLC/HMI/IPC based computer systems
• Prepared Software Test Cases & Executed Testcases.
• Assisting in functional testing of the new system, ensuring that it meets the user specifications.
• Executing testing activities and working with in deadlines.
• Documenting, tracking and communicating bugs, enhancements, analysis and unresolved problems.
• Completed Software Testing Course @VCTC institute.
• Knowledge of Agile scrum methodology
• Aware of SDLC,STLC and Defect Life Cycle
• Knowledge of Smoke testing, functional testing,Retesting and Regression Testing.
• Knowledge of Jira as a Project Management tool.
• Aware of Black box and White box testing

BE in Instru and Control – Govt. College of Engg, Pune (2021)

HSC – State Board (2017)

SSC – State Board (2015)