• Performed Validation on ERP-JD Edwards, HP-QC, LabWare LIMS v7.0 as 21 CFR Part 11 and cGxP Guidelines. • Worked on Global Quality System Legacy Validation initiative, aiming to define and harmonize requirements for the Validation of GxP applications, and to initiate remediation projects for GxP applications, associated to Computerized Systems processes.• Reviewed the various project deliverables, includes: Project Plan / Validation Plan / Migration Plan, FRS, Deployment Plan, Trace Matrix, Test protocols, Supporting Documents.• Developed Functional Requirement Specification (FRS) from User Requirement Specification (URS).• Developed Installation/Operation/Performance (IOP) Qualifications test scripts and executed them.• Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating. • Implemented cGXP’s (GMP, GLP, and GCP) guidelines in the systems.• Followed a standard process for using Electronic Signatures on all electronic-document transfers using the 21 CFR Part 11 standards with GAMP 5 regulations.• Reviewed the FRS and ensured the traceability against the Trace Matrix.• Reviewed and approved pre-approval UAT/Test protocols for requirement coverage, flow of steps and GDP.• Reviewed and approved post-approval UAT/Test protocols to verify the right documentation of test evidences.• Generated Validation Summary Report to summarize and document all validation activities.• Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system.• Updated SOP for a unique business function Article USP<1058>Analytical Instrument Qualification (AIQ).• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.• Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.

• Gathered URS, FS for LIMS Link applications.• Documented the IOQ validation protocols and reports for Crystal Reports.• Created Change Requests in Solman.• Documented Trace Matrix, Interim Report, PQ protocol and Final Report for Lot QC LIMS.• Documented the Functional Design Specification of INDUSTRIALIZING PRECISION MEDICINE - IPM QA application.• Documented the URS, RA for IPM and LIMS Link application.• Documented the IQ, OQ and PQ protocols for IPM and LIMS Link applications.• Created, reviewed, and routed requirements, test cases, test sets in HPALM.• Conducting data integrity Audit Trail for elements acquisition, sequencing, processing, reporting, and retention of GxP data. • Analyzing the Customer Requirements performing Risk assessment and deriving the Validation Scenarios/ Conditions based on the Requirements. • Validated in-house applications for compliance with the requirements and maintained the 21 CFR Part 11 regulations.• Performed Periodic Reviews of applications to ensure the applications follow was effective and detailed documentation, as per the Standard Operating Procedures.• Adept at performing various testing such as Integration, System, UAT, Integration Testing positive, negative testing and Usability Testing.• Reviewed existing validated documentation and analyzed all proposed change controls, vendor upgrades/patches to determine any course of action required to rectify defects.• Monitor and ensure Stage Gates are observed, executed, and signed off on Sample Stage Gate Documents for Quality auditing after each stage is complete.• Ensure collection of and review of SDLC Metrics including rework, root cause metrics

• Facilitated the implementation of a Quality System / Software which complies with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 Guidelines and GxP (GMP, GDP, GLP) Standards.• Authored and Reviewed Validation Summary and Test Summary reports, for every Change Request.• Maintained and documented the total number of tests executed in various test environments.• Authored Test logs created and uploaded the test scripts to HP ALM.• Involved in Preparation, Execution and Review of CSV documentation comes under GMP.• Created test instances and performed regression testing for patch attached to HP ALM.• Recorded the test defects identified during test executions, in the Defect module of HPQC.• Maintained the master list of pre-approved tests and post approved tests.• Provided the status of the test executions, performed in the various functional areas, using the Dashboard module in HP ALM. Pulled the test execution reports form HPQC.• Created Test Protocol Reports (TPR) using the Defect module in HPQC• Reviewed and identified the gaps from the test scripts in pre-approvals and post approvals and helped the functional teams to fix the errors and gaps during executions.• Reviewed the Business Process Definitions documents. Followed the change control process for the new/ change requirements.• Made sure the relevant approvals from the Business team for the change or new requirements. • Updated and uploaded the project deliverables on SAP.• Maintained the test deliverables for various Change Requests created in the multiple stages of the project.• Provided support to the various functional areas of the ERP systems during the End to End testing, Regression testing, System Functional testing, Integration testing and Unit testing.• Provided the record of t-codes and functional role profiles form the SAP functional areas to the OCM team.• Served as the primary liaison between business users and development team.

• Documented URS, Risk Analysis, IQ, OQ and PQ for Version Control, ERP systems and Data Solutions systems. Reviewed URS and FRS documents for Jira application. Documented Validation Plan, Test plan, Functional Specifications, Qualification Protocol and Test cases.• Focused on Electronic Data Capture (EDC)• Verifying the FMEA and Defining the process flow.• Generated the documents by using user manuals and the software’s, such as URS, FRS, Risk Assessment, Test Protocols and Validation Reports.• Reviewed Data sync functionality (e.g. screening, screen failure, completion, withdrawal) is used to ensure that when criteria and patient status data is added or updated in EDC it generates a message to also update the information in RTSM.• Reviewed RAVE e CRF (Correcting Data, eCRF workflow, Log Forms, Recording Study Data, Visits) validations• Author requirements for computer systems to ensure compliance with regulations such as 21 CFR Part 11, and cGMPs.• Work with internal groups in creating project documents and performing verification and validation testing required in an FDA-regulated.• Documented and tested the software’s in Risk based analysis (RA).• Involved in Validation of the labelling application and associated hardware in accordance with FDA's 'General Principles of Software Validation' and 21 CFR part 11 compliance.• Reviewed, organized Change Requests, and approved after verification of completeness of documentation.