- A Versatile and accomplished Computer System Validation (CSV) professional with 8 years of experience in pharmaceutical and medical device industries. Adept in navigating organizational ladder and influencing team members in accomplishing goals. To be given an opportunity where I can use my experience to company’s interest
- Excellent Knowledge in GAMP and 21 CFR Part 11 regulation of Electronic records, Electronic signatures, Audit trials and Documentation.
- Expertise of validation practices in FDA regulated environment with good understanding of cGxP (cGMP, cGCP, cGLP) standards.
- Good experience in Software Development Life Cycle (SDLC), comfortable with Waterfall, V - Model and Agile methodologies.
- Strong Expertise in preparing, reviewing and approving User Requirement Specification (URS), Functional Requirement Specification (FRS), Validation protocols Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Master Plan (VMP)
- Strong knowledge and working experience in executing Gap Analysis, establishing Remediation Plans, preparing Corrective Action Prevention Action (CAPA) and Change Control Process
- Hands on experience in DFMEA and PFMEA Analysis.
- Risk-based assessment on the Computer Systems to determine the required test cases
- Involved in preparing test artifacts like Test Scripts, Test Cases, Test Plans, Test Strategy, Test requirements and Testing standards based on URS
- Good experience in Functional Testing, Integration testing and User Acceptance Testing (UAT)
- Expertise in test management and defect management using HP ALM
- Involved in preparation of Requirement Traceability Matrix (RTM), Validation Summary Report (VSR), Defect Report, and Weekly Status Reports
- Good knowledge of FDA Medical Device Reporting and International medical device regulations including 21 CFR parts 820
- Strong expertise in developing successful data migration plans while working with development teams
- Worked with Laboratory Information Management System (LIMS), OpenLAB CDS (chromatography data system), Change Control Management System (CCMS)
- Working knowledge with Documentum (EDMS), TrackWise, JIRA
Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGxP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, CAPA, VMP, Risk Assessment, Summary Reports, Audit Trails
SDLC Methodologies: Waterfall, V-Model, Agile
Tools: MS Office (Word, Excel, Power Point, Access Visio), Documentum, JIRA, HP ALM, MS SharePoint
Confidential, Foster City, CA
Sr. Validation Analyst
- Responsible for documentation of all aspects of the Computer System Validation (CSV) Life Cycle in accordance with 21 CFR Part11, xGLP and xGDP.
- Participated High Level Risk Assessment (HLRA) session to determine if the system is GxP
- Participated in Vendor Assessment for vendor selection
- Prepared work flowcharts In MS Visio to illustrate the User Requirements
- Developed Master Validation Plan for the implementation of the new application
- Involved in drafting the User Requirement Specifications (URS) and Functional Requirement Specification (FRS) by conducting meetings with the users.
- Executed risk assessment using DFMEA, PFMEA
- Authored and Documented Validation Protocol documents like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Developed and maintained Requirement Traceability Matrix (RTM) to track the requirements
- Performed dry runs to check if the test cases have covered the functionalities, which need to follow 21 CFR Part 11 rules set by FDA.
- Lead the team in the formal test execution of test scripts and documented the deviations
- Involved in GAP analysis for user requirements verification and devised remediation plans
- Performed deviation investigations, root cause analysis, and implemented CAPA s to business units which improved efficiency in accordance to compliance
- Authored End-User Training Manuals and SOP’s
- Prepared and documented Validation Summary Report (VSR) including Deviation investigation, Resolution and Quality System Development Data Migration Activities:
- Gathered the Business Requirements to move from the legacy system to new system
- Authored Data Migration Strategy and Plan
- Prepared Source to Target Detailed mapping document & Transformation rules document
- Participated in pre-migration testing and post-migration testing
Confidential, Somerset, NJ
Sr. Validation Analyst
- Followed Computer Systems Validation Master Plan to prepare, review and approve CSV deliverables like User Requirement Specifications (URS) and Functional Requirement Specification (FRS) as per GxP guidelines
- Involved in sessions with Subject Matter Experts, Business Sponsors and Owners and system owner to draft the Change Requests
- Assessed Quality, Compliance, Business and Infrastructure impact of the Change Request (CR)
- Performed risk assessment and prioritized Change Requests and ensured the Change Requests are moved accordingly
- Reviewed and approved change requests after verification of completeness of documentation like Change Request Form, Change Control Implementation Plan and Change Control Summary Report.
- Participated in internal audits for evaluation of compliance with the Quality System Regulations
- Developed Validation Protocols ( IQ, OQ, PQ ) as per the specifications and requirements
- Authored, reviewed and maintained Traceability Matrix (RTM) document
- Prepared procedural Test script and test cases for the new requirements
- Participated in reviewing Corrective Action and Preventive Action ( CAPA ) and drafting
- Performed Document Reviews to be compliant according to FDA guidelines and GAMP5
- Developed templates, SOPs and manuals for validation
- Prepared Test Summary Reports and Validation Summary Report (VSR)
- Worked in compliance with 21 CFR Part 11 and cGLP regulations for this project.
- Developed and reviewed User Requirements Specification (URS) and Functional Requirements Specification (FRS) artifacts
- Participated in writing the Test Plans, Reusable Test Strategies, Test Scripts, Retractability Trace Matrix ( RTM ) and Test Summary Reports for executing test scripts according to SOPs
- Involved in the execution of IQ/OQ/PQ protocol for the application
- As per the FDA regulations under 21 CFR Part 11 , documented various validation deliverables of system life cycle
- Performed Integration testing, System testing and User Acceptance Testing (UAT) for the test cases
- Lead the team in the dry run of OQ and UAT test scripts in Development environment and formal testing/execution of the OQ and UAT test scripts in Validation test environment
- Developed End User Training Manuals
- Worked with off-shore team to discuss the testing activities and escalating issues during the daily meeting minutes
- Prepared the Validation Summary Report (VSR) summarizing the validation activities that were performed for the LIMS application
Equipment Validation Engineer
- Drafted User Requirement Specifications (URS) and Functional Requirement Specification (FRS) as per the regulatory guidelines
- Designed jigs and fixtures in SolidWorks as a part of tool setup in the new manufacturing facility
- Prepared and documented Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiments (DOE), Process Failure Mode Effects Analysis (PFMEA)
- Performed Commissioning and Qualification (C&Q) activities for manufacturing lines including Site Acceptance Testing (SAT)
- Assisted in procedure development and maintenance, capability studies, Gauge R&R, first article reports
- Developed the Risk Assessment and Corrective Action (CAPA) for current procedures manufacturing equipment
- Wrote all Change Request (CR) assessments to evaluate any change to the manufacturing process in relation to validation
- Wrote comprehensive investigation reports to evaluate and troubleshoot manufacturing problems in support of the change control program.
- Prepared Retractability Trace Matrix (RTM) and Validation Summary Report (VSR)