Management System Software Development

Name: vineeth reddy

Email: ***********@*****.***

Mobile: 860-***-****

Professional Summary:

●6years of experience in Validation as a Sr. Computer System Validation/Test Analyst, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part 210, 211, 820 compliance and GAMP 5, GxP’s (GMP, GLP and GCP).

●Worked in a variety of Computer System Validation Projects:

●Labware LIMS (Laboratory Information Management System),

●Watson LIMS,

●Clinical Trial Management System (CTMS),

●Veeva Vault (QDocs, QMS),

●Track Wise (CAPA, Change Control Management workflows),

●Windchill PLM,

●Discoverant,

●ServiceNow (ticket and process management),

●Argus Safety,

●SAP ERP,

●Document Management System (DMS) SharePoint based.

●Experience in various types of testing methods such as Regression testing, Positive testing, Negative testing for User acceptance Testing (UAT)/Performance Qualification (PQ), Unit Testing/Installation Qualification (IQ) and System Functional Testing (SFT)/Operational Qualification (OQ) using testing tools (HP/Microfocus ALM), JIRA.

●I am very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).

●Expert in using Quality Center/HP ALM, JIRA for reviewing/approving tests and defects.

●Experience in providing training to business users on Good Documentation and Test Execution Practices.

●Excellent knowledge of GLP, cGMP and GAMP5 guidelines.

●Demonstrated capabilities to quickly gain a detailed understanding of a process to optimize efficiencies, reduce cost, and performed various boundary tests as well as positive, negative testing based on the Risk class.

●Experience in executing software validation protocols (installation, operational and performance qualifications.

●Able to handle multiple priorities and determined to get the job done correctly on time for an allotted project.

●Excellent interpersonal, organizational, verbal, and written communication skills.

●Excellent knowledge and experience in Good Documentation Practices and ALCOA (data integrity principles).

●Good understanding of Initiation, Control and Executing Validation Processes and procedures.

●Possess solid research skills, analytical thinking, problem solving skills and positive attitude.

●Excellent oral and written communication skills.

Technical Skills:

Tools:

HP QC/HP ALM, Jira, QTest, Kneat, Val Genesis (VLMS), MS Office Suite, MS Visio, MS Project.

Validation Skills:

Risk Based approach, Computer System Assurance (CSA), GAMP 5, Supplier, Vendor Assessment,

Cloud Applications.

FDA Regulations:

21CFR Part 11, 210-211 (cGMP’s), GAMP 5, 803 (Medical Device Reporting), 820 (Quality System Regulation).

Validation Deliverables:

Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, IQ, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report.

Professional Experience:

Client: Abbott, CA Dec 2022 – present

Role: Sr. CSV Analyst

Projects: Labware LIMS (Laboratory Information Management System), Watson LIMS, Clinical Trial Management System (CTMS), Veeva Vault (QDocs, QMS), Track Wise (CAPA, Change Control Management workflows).

Responsibilities:

Followed Computer Systems Validation (CSV) Master Plan to author and review CSV deliverables for systems as per GxP (GLP, GCP, and GMP) FDA Assessment.

Applied knowledge of regulations like FDA 21 CFR Part 11 and performed part 11/ERES assessment.

Involved in the creation of Validation Plan, Verification Protocols and Verification Summary report documents.

Worked on the entire validation life cycle for Lab instruments (benchtop) validation. Created Validation documents for Lasers, Filters.

Worked with different project teams on understanding the Software and Instrument in scope of the project.

Guided teams on validation and testing best practices.

Conceives, plans and executes manufacturing process validations plans and studies.

Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.

Worked with teams to draft the Validation Plan, Validation summary report, Data Migration Plan and Data Migration Summary Report.

Analysed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation electronic records and following relevant SOPs.

Perform risk management assessment on all systems under validation.

Perform Functional Verification/Validation Testing as per the features of the product.

Provided validation guidance to technical teams to ensure compliance to the regulations like 21 CFR Part 11, GDP and GMP.

Handled RCH/PCH - Routing in MAP Agile & follows up till release.

Developed Validation Master Plan (VMP) in accordance with company SOP.

Developed/Reviewed OQ/PQ protocols by identifying high and medium risk requirements and developed appropriate test strategies.

Involved in preparing test and validation summary reports.

Involved in the creation of Validation deliverables Validation Master Plan (VMP), Validation Summary Reports (VSR), Risk Assessment, part 11 assessment, Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix.

Managed execution and verification of evidence of OQ and PQ tests.

Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirements.

Experience in Data Migration, Periodic Review, Change Controls, and Risk analysis, CAPA, FMEA and Remediation Process.

Updates Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD).

Prepares protocol & executes Test Method Validation (TMV).

Applies validation experience using risk-based approach guidelines, international regulatory requirements, and standards.

Client: Bayer Pharmaceutical, CA Feb 2022 – Nov 2022

Role: Sr. CSV Analyst

Projects: Veeva Vault (QDocs, QMS), Discoverant, ServiceNow (ticket and process management), Argus Safety, SAP ERP.

Responsibilities:

●Authored Validation Plan, Risk Assessment, Qualification/Test Plan, Validation Summary and Test Summary reports.

●Created and executed OQ/PQ Test Scripts for Labware LIMS and CTMS, Veeva Vault.

●Created Qualification plan (Test Plan) to document testing strategy based on requirements gathered.

●Authored Test logs created and uploaded the test scripts to HP ALM.

●Created Test instances and performed regression testing in HP ALM.

●Recorded the test defects identified during test executions, in the Defect module of HP ALM.

●Involved in Design, Development and Management of multiple computer systems Validation deliverables and life cycle in accordance with the 21 CFR part 11 and companies SOPs.

●Experience in performing Periodic Review, Change Control management, and Risk analysis, FMEA process.

●I analyzed the test data for dry run and formal test execution for functional and user acceptance testing for different phases.

●Tracked and Maintain Traceability Matrix between Requirements, Test cases and Deviations.

●managed the testing activities like test preparation, execution and defect management process and test execution status report using HPALM.

●Developed high level and detailed process maps in defining the use cases for documenting the test scenarios and test scripts.

●Validated applications meet GAMP 5 and 21 CFR Part 11 FDA Regulations

●Worked on Validation Veeva 19R3 to 21R1.

Client: Resilience, CA May 2021 – Jan 2022

Role: CSV Analyst

Projects: Watson LIMS (ensure compliance with regulations and company SOPs, Track Wise (CAPA, Change Control Management workflows), ServiceNow (ticket and process management), Windchill PLM, SharePoint.

Responsibilities:

●Created Qualification plan (Test Plan) to document testing strategy based on requirements gathered.

●Authored Test logs created and uploaded the test scripts to HP ALM.

●Created Test instances and performed regression testing in HP ALM.

●Recorded the test defects identified during test executions, in the Defect module of HP ALM.

●Maintained the master list of pre-approved tests and post approved tests.

●Provided support to the various functional areas of the systems during the Operational Qualification (OQ) and Performance Qualification (PQ) (End to End testing, Regression testing).

●Created Trace Matrix document to link requirements to testing.

●Reviewed the Business Process Definitions documents. Followed the change control process for the new/ change requirements.

●Prepared Validation Master Plan (VMP) for validating cloud system (SaaS – Software as A Service).

●Developed Functional Requirement Specification (FRS) from User Requirement Specification (URS).

●Performed Vendor Assessment and reviewed vendor documentation to be leveraged during validation life cycle.

●Tracked and managed the testing activities like test preparation, execution and defect management process and test execution status report using HPALM.

●Facilitated vendor meeting and maintained close communication with project team members to meet the testing and project timelines.

●Validating processes in cGMP environment as per FDA guidelines.

Client: Mylan Laboratories, India Aug 2017 – Nov 2019

Role: Validation Analyst

Projects: Argus Safety, SAP ERP, Electronic Document Management System (EDMS) SharePoint based, Data Migration.

Responsibilities:

●Played an active role as a Validation analyst to complete the CSV projects as per the project plan.

●Worked on multiple change controls for all applications.

●Prioritized Business Requirements and segregated them into high risk and low-risk requirements by discussing with user and by performing detailed risk assessment.

●Developed Master Validation Plan for all the assigned CSV projects.

●Reviewed and updated templates for validation protocols, validation reports.

●Reviewed the end-to-end Validation deliverables like Overall risk assessment, Supplier assessments, ERES assessments, URS, VP, FRS, FRA, IQ, OQ test plans and scripts, RTM, ERES assessment, discrepancy forms and VSR.

●Coordinated with the project manager, developed timelines for project delivery and managed projects and resources with the Project manager to successful completion.

●Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.

●Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and the IQ/OQ/PQ test script references.

●Developed, Modified and reviews SOPs, Operating Manuals, and User guides.

●Conducted Risk Assessment sessions to analyse the GxP, Business and functional impact on the user requirements with process owners.

●Coordinated testing efforts with business users and validation team.

●Coordinated with QA team for Validation and Test plan approval and conducted meetings between technical team and stakeholders to move the validation efforts forward.

●Created validation status reports and provided validation status to the PMO group.

●Assisted in documentation and development of system specific SOPs (User Access and Admin).

Education: Master’s in healthcare informatics, Sacred Heart University, Fairfield, CT.

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