- Over 6 years of experience in Computer System Validation and knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, SDLC and SOX and other GxP Regulations.
- Strong and diverse experience in Technical writing.
- Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
- Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulations.
- Superior knowledge of 21 - CFR Part 11 regulation and GxP’s (GMP, GLP and GCP).
- Involved in Change Control and developed Change Notification Form (CNF).
- Working experience with ensuring compliance to Part 11, 820, GAMP and ICH guidelines.
- Extensive experience in User Interface (UI) designs, content management and working with wireframes.
- Experience with Content Management system such and Document Management System. Experience in Developing and Executing Test Plans, Test Procedures, Test Scripts, Test Cases, Test requirements and testing standards.
- Experienced in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
- Acquaintance in Method validation of almost all Analytical instruments.
- Involved in Data Migration Plan.
- Skilled in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations
- Excellent experience in validating wide variety of applications and infrastructure - Excel spreadsheets, Electronic Document Management System (Documentum), Track Wise, Clinical trial management system.
- Steep knowledge of calibration to carry out Validation Testing
- Performed Regression, System and UAT testing using both HP Quality Center and HP Application Life Cycle Management (HP ALM) and paper based manual testing
- Experienced in managing schedules, deadlines and resources using MS Project considering the Triple Constraint and creating Work Breakdown Structure (WBS) and MS PowerPoint presentations for management review.
- Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.
- Knowledge in Automated Testing tools like Quick Test Professional (QTP), Unified Functional Testing (UFT) Win Runnerand Quality Center.
Validation skills: 21CFR part 11, cGMP, cGLP, cGCP, and 21CFR part 820
Analytical Software: Windchill
Testing and Tracking Tools: HP Quality Center, Manual testing
Databases: Oracle Argus
Applications: CTMS, PLM
Operating System: Windows OS, Vista
Confidential, New Jersey
- Reviewed, coordinated and maintained CSV Change Controls.
- Maintained the laboratory in accordance to established cGMP, GLP, & 5S industry standards, conducted monthly audits of laboratory procedures and testing/product flow processes to identify potential areas needing focused improvements, and participated in internal and FDA audits as required.
- Close interaction with designers and software developers to understand application functionality and navigational flow.
- Created Dummy data to execute the Test scripts. Performed manual testing in all different environments.
- Performed Risk analysis.
- Performed formal validation QA environment and captured all the evidence where ever necessary as per the Test script.
- Reviewed all the Test script and made sure that all the Pre - approvals are done to execute the test scripts in QA.
- Develop Training Plans, Testing strategy reports, Testing Summary Reports and WI, SOP.
- Developed the Functional Requirements Specification of LMS by interacting with business users and development team and by using User Requirements Specification document.
- Collected User Requirements (URS) for Trackside by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements.
- Assisted in authoring, and reviewed and approved CSV deliverables (Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report).
- Prepared test data for Positive and Negative testing.
- Developed test plans and test cases for Functional and Regression Testing.
- Followed good test practices to document the test evidence (Screen shots), Deviations, Resolutions, and Corrective Actions.
- Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
- Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
Confidential, Mahwah, NJ
- Authored Training manual and SOP’s. Updated all the Training manual to meet the current workflow.
- Extensive experience working as a Validation engineer for FDA regulated, mission critical GXP Pharmaceutical Systems in the Global Solution delivery model (Offshore- Onshore).
- Responsible forAnalyzing and Reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, and System Design Specification document.
- Involved in internal mock audit by quality organization.
- Authored Happy Path Scripts For UAT and provided the users with all the support needed for them in UAT to understand the current process and how it is different from the old workflow.
- Performed Dry run of all the Test scripts and recorded all the Deviation through the Issue Log in all the environment.
- Assisted in drafting the Test script for New Requirements by following the GDP guideline.
- Performed Informal User Acceptance Testing in the INT environment andTracked all the issue through a Deviation log.
- Responsible for Routing the documents and also ensuring that All the script is PRE approved for QA validation and Execution.
- Reviewed al, the QA executed scripts and ensure all the evidence has been collected and all the Deviation were captured and Documented.
- Ensured all the QA scripts and Evidence have been Post Approved before uploading to the Share point.
- Analyzed all the issue by maintaining track of the issue which were recorded in DEV and whether similar issue was recorded in INT and made sure they were fixed both in DEV and INT.
- Performed the Formal validation in QA and reported Deviation through the Standard Deviation log.
- Expertise in Identifying the bugs and analyzing the bugs are system related or script error.
- Analyzing the issue by keep track all the issue that were recorded in INT, QA and made sure the issue was fixed both in QA and INT environment.
- Updated the developer team with all the issue encountered during Formal Validation in QA and keep a track of Promotion issue to verify them In PRD environment.
- Expertise in creation of Dummy dataand creation of Drawing and also association the parts and Drawing as per the Test setup for the Test script.
- Expertise in Windchill and all the new workflow for all the Seven type of CA Drawing Design CA, Drawing Transfer CA, Drawing Finalize CA, QMS CA, MFG CA, External CA and Inspection CA.
- Assisted in identifying the Test script for Production testing to ensure that code promotion process was done successfully as Post GO live Activity.
- Assisted the IT Team in all the documentation like AIQ, Promotion documents and also uploading all the QA scripts and evidence to the share point.
- Assisted in validation test summary report, validation summary report and also assisted in bulk configuration of the user groups as a Pre - Go- live Activity.
- Analyzed the Business requirements and assisted in preparing the Validation Master Plan and Validation Plan.
- Used CTMSapplication which has modules like Study templates, Accounts, Payments and reviewing result data
- Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
- Reviewed and developed validation deliverables- master plan/Summary Report, URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols
- Involved in performing the GAP Analysis of the system. Developed Risk Assessment and Deviation Report.
- Dry running of the test script and updating all the system issue through the Deviation log and retesting the issue once they were fixed and closed the open issue.
- Expertise in analyzing the issue whether it is a system issue or a script error and act accordingly.
- Assisted the IT team with all the IS documentation such as Test Summary Report, Deviation log, Promotion Document.
- Responsible for managing documents in the corporate document management system.
- Responsible for documentation of all aspects of the Computer System Validation Life Cycle. deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
- Develop test procedures/test cases and test tools.Developed and executed IQ, OQ, PQ protocols and test cases stored in the Test Plan and reported deviations using HP Quality Center.
- Hands on experience with QUMAS document management system.
- Responsible for inspecting applications in the regulated pharmaceutical sector in accordance with GXP systems.
- Worked on pre-execution approvals for UAT test scripts that are automated for Regression Testing.
- Worked on post-execution approvals for UAT scripts, which involves Manual and automation.
- Reviewed defects and closed in Mexico Regression test cycle
- Reviewed and approvedRegression test protocol (RTP) and Regression Test Reports (RTR), Regression Summary Report (RSR). Responsible for retrieving, archiving and maintaining SVP documentation (URS, arch diagrams, CR docs)
Confidential, New Jersey
- Involved in creating System operational and Administration SOP’s.
- Performed Periodic Reviews on regulated production computer systems
- Developed test plans, test strategies, test scripts for validation testing along with the TestSummary Report.
- Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP)
- Responsible for reviewing and executing IQ/OQ/PQtest scripts.
- Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP quality center and executed them. Executed validation test cases based upon system requirement and FDA standards.
- Developed and updated the Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
- Developed Issue log in all the Environments where testing was done and updated the issue log accordingly.
- Coordinated the UAT by setting up all the data for the users, provided support in the UAT by walking through the new workflow.
- Performed functionality testing for the entire application. Responsible for weekly status reports, updated showing the progress of Manual testing effort and open issues to be resolved.
- Experience throughout software lifecycle, following FDA guidelines.
- Developed Technical specification, Use cases, data model etc.
- Reviewed Validation Protocols from the manufacturers to ensure that the process meets FDA requirements, complies with cGAMP’s and company policies and procedures.
- Assisted in on-going process improvement efforts to ensure Test Planning, Execution, and Reporting is effective, efficient, standardized, coordinated, and integrated.
- Submit and maintain defect reports using PVCS - Tracker defect tracking system.
- Executed Quality Controls and Quality Assurance to improve the standards of the services.
- Developed and implemented the Quality plans for the process and involved in Audits and performed the quality check to verify the performance of the services.
- Validated EDMS to ensure 21CFR Part 11 (electronic records, electronic signatures).
- Worked closely with Business Owners and Stakeholders to outline Business Requirements.
- Hands on experience in pharmaceutical device verification and validation
Technical support lead
- Install Maintain, Calibrate, Inspect and Repair medical equipment and instrumentation.
- Perform preventive maintenance and electrical safety testing of clinical equipment, devices and systems.
- Applied principles of cGMP, GAMP as related to product design Authored and reviewed Requirement Traceability Matrix (RTM).
- Expertise in calibrating and validating laboratory instruments like Plate Readers, TOC analyzers, Spectrophotometers, Fermenter, and Reactors
- Troubleshoot equipment problem, identified the need of new equipment and made modifications to the existing equipment to obtain throughput and reduce process cycle time
- Maintain documentation on equipment, inspections, and equipment repairs and failures.
- Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using HP QUALITY CENTER and paper based manual testing.