• Lead the Data Integrity and Remediation Plan (DIARP) program at site level for the remediation of DI and remediation of identified GAPs.• Developed CSV and CQV operational strategies by establishing governing policies/procedures. • Generation/oversight of CSV Validation Master Plans for all Catalent manufacturing sites. • Managed CSV projects at both sites, including the oversight of CSV projects and contractors. • Served as the Validation point of contact for all CSV projects/tasks and SME for FDA/client audits. • Actively participated in the selection process of all new eSolutions introduced at Catalent sites, engaging the projects at an early stage of the process to ensure CSV compliance.

• Served as a project manager for validation/qualification aspects of complex projects according to 21 CFR Part 11 regulations and Data Integrity compliance in targeted areas. Arranges for contract validation services when required. • Ensured that the system’s validation state is maintained through proper testing as part of the change control program and re-validation as necessary and perform a periodic review of systems to monitor the validation status of the system as well as an annual security audit.• Authored validation plans (VP/PVP), Risk Assessment/Failure Mode Effective Analysis (FMEA), Specification documents; Oversee and provide direction for the development of specifications for user requirements (URS), functional requirements (FS), and design requirements (DS), trace matrices, validation summary reports and test protocols for installation, operation, and performance of software and equipment. • Developed and modifies of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates including test cases.• Worked as a Validation Manager for SAP Changes and SAP Upgrade Projects – Reviewing and Approved Configuration/Design Specification Document and Test Results in HP ALM.• Mentored and trained colleagues on policies and procedures including the requirements for validation.

. Prepared Standard Operating Procedures (SOP) for the day-to-day maintenance of the applications and underlying systems.. Ensured ITIL and FDA part 11, part 820 practices are followed diligently at all times.. Defined, designed, implemented validated systems in compliance with FDA specifications and Changecontrol.. Responsible for validating Computerized Systems, including Enterprise Integration Systems andMES applications.. Ensured proper retention polices are in place to validate the computerized systems.

• Interacting with Country Teams and Translate Team to ensure all the Pre-Verification & Validation (V&V) documents are translated and approved before release.• Creating Action Items for all the Pre-V&V documents using JIRA.• Executing Installation Qualifications in Validation Environment (VAL) using HP ALM.• Reviewing the Operational Qualification (OQ) scripts by checking for any Good Documentation Practice (GDP) issues.• Creating Localization defects for any issues found in VAL Execution using JIRA.• Coordinating with Quality & Project team to make sure all the documents/scripts are validated & approved.

• Worked with facility Subject Matter Experts to document user requirements • Updated and developed application system User Requirements, Functional, and Design Specifications for Serialization system (TraceLink), according 21CFR Part 11 and GxP regulations. • Developed User Acceptance Test scripts (UATs) based on requirements and reviewed UAT execution results. • Wrote SOP documents for computerized systems and CSV process. • Generated Release Matrix documentation for Batch Releases and approve all Batch Release documentation in QualityDocs (QD).

Developing plan and leading product Process Improvement and process scale-up, including determining process parameters.Preparing Change Control Records (CCRs) for support of Technical Transfer Projects, process scale-up, and process improvements.Participating in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA).Developing and Managing of Continuous Process Validation Program.Executing Validation Protocols for the Commissioning Qualification (CQ) and equipment qualification.Working on on Commissioning Qualification (CQ) of manufacturing equipment and analytical laboratory equipment, and qualification of computerized systems.Working on GAP analysis for 21 CFR Part 11 assessment.

• Created and designed training courses for all modules of HP Application Lifecycle Management (ALM) v12.2 using HP ART (Adoption Readiness Tool).• Worked on creating and updating user accounts for HP ALM tool for sandbox environments.• Created voice over recordings for HP ALM Training courses. • Authored User Requirement Specifications (URS)/Functional Specifications (FS)/Design Specifications (DS), Validation Plan, and IQ/OQ/PQ Qualification Protocol documents for Network and Application qualification, according to 21CFR Part 11 and GXP regulations. • Worked on Infrastructure Design/Configuration Document, Infrastructure Qualification Plan, Infrastructure Qualification Protocol (IQ/OQ), for the qualification of Infrastructure (Hardware and Software).• Validated systems with Electronic Records and Electronic Signatures according to GXP regulations. • Created requirements, test scripts, test sets, and defects for Qualification testing in HP ALM.• Exported User and Functional Requirements to HP ALM for Trackwise V 8.5 application.

• Worked on Requirement Specifications – User Requirement Specifications (URS)/Functional Specifications (FS)/Design Specifications (DS), Validation Plan, Risk Assessment, Installation Qualification (IQ)/Operational Qualification (OQ)/ Performance Qualification (PQ) Qualification Protocol, Qualification Summary reports for applications Trackwise, BaxEDGE, and Network/Network Tools Qualification, according to 21 CFR Part 11 and GXP regulations of USFDA.• Worked on Infrastructure Design/Configuration Document, Infrastructure Qualification Plan, Infrastructure Qualification Protocol (IQ/OQ), Infrastructure Qualification Interim/Final Reports for the qualification of Infrastructure (Hardware and Software).• Reviewed and approved Infrastructure Change Controls in Remedy Application, as an Infrastructure Quality System Representative (IQSR). • Reviewed and approved Change Controls for Application Upgrade/Changes as a Quality System Representative (QSR), as per CAPA procedures. • Reviewed and approved Requirement Specifications Documents, Validation Plan, Risk Assessment, IQ/OQ/ PQ Protocol documents, Qualification Summary reports, Master Qualification Plan, and Test Cases for qualification of Pharmacovigilance (PV) SharePoint Tools Application, Training Documentation and Tracking System (TDTS)/Isotrain Application Projects.• Helped in Documenting Audit Response for PV Share point Tool Projects. • Team Mentor in guiding other team members for Qualification projects and training the Validation Leads.• Participated and provided guidelines in team meetings for the CAPA process improvement in Computer System Validation (CSV).• Organized Test Case Management, Defect Management, Release Management, Reports Generation, using HP Quality Center (QC) and HP Application Lifecycle Management (ALM).

• Followed SOPs of the company for documenting Validation Plan, Test Cases and Test Scripts based on Business Requirements.• Asserted validation documentation for complying with cGMP sensitive transactions.• Complied with SOP's Standard Operating Procedure per FDA regulations.• Lead the Validation efforts of Trackwise (Infrastructure and Application) and Data Center Setup projects.• Defined the validation approach for all the projects.• Provided technical instruction training material referencing Track wise for FDA Regulated GMP docs.• Involved in validating computer system interface with laboratory equipment’s such as Spectrophotometer, HPLC, GC and Autoclave.• • Managed and organized Test Case Management and Defect Management using Quality Center. • Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.• Wrote performance qualification protocols, executed protocols, and prepared final reports; identified/or assisted system owner to identify systems that are GxP and 21 CFR Part 11 relevant. • Prepared Part 11 assessments and remediation strategies.