• Coordinated with Management to address the need of required documents to bring the system and infrastructure components fully compliant with FDA regulation and company’s policies and procedures.• Documented, reviewed, and approved 21 CFR Part 11 Assessment and GxP Risk Assessments including Application Risk Rationalization Assessment and ERES Assessments.• Authored Integrated Risk Management Reports and Application Risk Assessment Worksheets.• Partnered with Quality Assurance personnel to review and approve validation deliverables.• Involved in all GxP Testing activities IQ, OQ, PQ test script preparation and test executions including deviations if any.• Worked with CAPA team to root cause of issues and preparation of deviation reports.• Performed pre & post approval reviews for test scripts of Sample Manager LIMS.• Conducted data validation and verification.• Reported the defects in HP Quality Center and involved in Regression Testing.• Conducted Audit trails - 21 CFR part 11 for GMP.• Involved in Test script development and data validations.

• Lead validations and qualifications for TrackWise, MES and LIMS.• Reviewed and approved Design Specifications, Business Requirements, Installation Plan, System & UAT Test Scripts• Reviewed and approved system related IQ and OQ for the IT infrastructure components.• Reviewed and approved the system related SOPs to ensure compliance of company’s processes, policies, and procedures.• Reviewed and approved the Validation Assessment for the management to provide them a brief review of objectives to be covered during validation.• Performed and implemented technical and peer reviews of product documentation.

• Planned, executed, and documented Windchill PLM upgrade from 8.0, 8.3.5 and 8.5.2.• Used Windchill PLM for change initiation requests.• Documented User Requirements, Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description document.• Developed Validation Plan and Master Test Plans to strategize the validation approach as well as test approach in various test cycles.• Responsible for the validation of Windchill PLM.• Performed 21CFR Part 11 and GxP assessment • Participated in reviewing and approving CSV validation protocols and change controls.• Investigated and solved the variations from CSV validation findings.• Reviewed and approved end to end validation documentation for Windchill to ensure compliance with company policies and procedures.

• Partner with teammates to design incisive and meaningful risk-monitoring measures used for decision making and maintain overall data integrity.• As Validation Analyst worked with clients, vendors, IT and business groups to successfully manage timelines and objectives for SAP and D2 for Lifesciences (Documentum).• Implemented Procedure Approval, Change Request, Document Periodic Review, Document Withdrawal, Labeling and Marketing workflows in Documentum.• Responsible for reviewing and approving Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) • Configured and validated different lab system software according to User and CFR Part 11 requirements.• Document functional requirement specifications and prepare use case documents for functionalities in each release.• Constant review of standard operations (application functionalities) code for optimizing execution time.• Responsible for reviewing and approving all the validation deliverables • Reviewed and approved FDS and TDS for custom objects (RICEWF objects)

• Performed end to end validation activities for TrackWise.• Responsible for performing Data Integrity checks on Source and Target data.• Reviewed and approved functional requirements specification.• Involved in a team to prepare software validation protocols for TrackWise• Drafted end to end Validation deliverables for AERS • Responsible for validating CAPA and Complaints modules of TrackWise.• Responsible for authoring CAPA and Complaints modules scripts.• Created Process Flow documents for CAPA and Complaints modules in TrackWise• Executed the CAPA and Complaints modules scripts.