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Sagarika - Validation Engineer in Pharma

[email protected]

Location: Chester, Pennsylvania, USA

Relocation:

Visa: H1B

Sagarika Validation Engineer in Pharma 848-849-9879 [email protected] Chester Springs, PA H1B SUMMARY: Over 9 years of experience in Validation in pharmaceutical and medical device industry. Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ). Expertise in documenting User Requirement Specification (URS), Functional Requirement Specifications (FRS) and Requirements Traceability Matrices (RTM). Created and executed validation Test Scripts and document test results in accordance with standards. Experiencing in performing Risk Assessment for various COTS applications. Good knowledge of Regression Testing, System Integration Testing (SIT), User Acceptance Testing (UAT), Data Integrity, and Data Migration. Authoring/reviewing all the SDLC deliverables i.e. Validation Plan, Requirements Specifications (URS/FRS), System Integration Test scripts, Development Summary Report, Installation Qualification, User Acceptance Testing, Requirement Trace Matrix, Validation Summary Report, and System Document Index. Working experience in computer system validation in compliance with FDA guidelines, including Laboratory Information Management System (LIMS), Empower, Adverse Event Reporting System (AERS), Electronic Document Management System (EDMS), TrackWise, Veeva Vault Regulatory Information Management System and Change Control Management Systems (CCMS). FDA regulated environment with good understanding of cGxP (GLP, GMP, GDP and GCP), GAMP 4, GAMP 5 and Risk Assessment. Experiencing in Corrective and Preventive Actions (CAPA) and suggesting remediation plans to mitigate the non-compliance. Good knowledge of 21 CFR Part 11,210,211, 820 and EU Annex 11. Hands on experience working on HP Quality Center, HP ALM, and also proficient working in Manual testing environment. TECHNICAL SKILLS: Validation: FDA regulations, 21 CFR Part 11,210,211,820) GxP environments (GLP, GMP, GCP, GDP, GAMP 4 and GAMP 5), EU Annex 11, Validation Plan, IQ/OQ/PQ protocols, Validation Summary Reports, TSR, RTM, System Risk Assessments, Change plan, Change Summary Memo and VMP. Office tools: MS Word, MS Excel, MS Power point, MS Office, and SharePoint. Analytical software: LIMS, Adverse Event Reporting Systems (ARISg ), CCMS , TrackWise, Empower, EDMS, Quantitative Systems Pharmacology WorkBench (QSPWB) , SevenBridges, DNA Nexus, HUB-Artwork Management System, Customer Relationship Management Solution (CRMS, Moxie (a salesforce application)) and Veeva Vault Regulatory Information Management System. Testing Tools: HP QC, HP ALM, IBM DOORS, IBM Rational Clear Quest Operating Systems: UNIX, LINUX, and windows7/8. Methodologies: DevOps, Agile model, Waterfall model, V- model and Spiral model. EDUCATION: Bachelor of Pharmacy, Osmania University, INDIA. Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices, Boston, MA. PROFESSIONAL EXPERIENCE: Software Quality Assurance (SQA) Specialist Jan 2021- Current Abbvie Inc, NJ Responsibilities: Assisted project teams in planning, preparation, review, and approval of quality documentation. Reviewed and approved change requests in ServiceNow for Assessment, implementation and closing of the Change Requests Assisted in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout the quality system. Reviewed controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures. Participated in daily stand-up scrum, refinement, and planning meetings. Responsible for reviewing and approving user stories, QA defects, production defects, and also quality gates for DevOps process i.e. User Stories, Test Execution Acceptance and Release summary. Worked effectively in DevOps environment by collaborating with multiple teams to achieve sprint goals within the timelines. Identified, communicated, and resolved issues that may impact document timelines. Recommended process improvements that could reduce recurring errors in documents. Performed periodic reviews for various systems. Provided SDLC and regulatory guidance to the project team members. Reviewed and approved SLDC deliverables (Validation Plan, Requirements Specification, IQ, OQ, UAT Test Scripts, Requirements Traceability Matrix, System Administration SOP, System User SOP and User guides, Validation Summary Reports) upon request to ensure adherence to SDLC, policies and procedures, and system specific planning documents in accordance with agreed-upon timelines in tools like KNEAT and Confluence tools. Used JIRA to review the user stories. Reviewed and approved Installation Qualification, Operation Qualification and User Acceptance testing formal test executions in HP ALM. Involved in Defect approvals in HP ALM. Involved in Data Migration activities and responsible for reviewing and approving deliverables such as Data Migration Plan, Data Migration Summary, and other impacted deliverables. Reviewed and approved system related SOPs. Participated in training and education programs for various aspects of quality assurance. Managed multiple projects / efforts concurrently. Sr. Validation Risk Analyst May 2018 - Dec 2020 Merck & Co Inc, NJ As a Validation Risk Analyst, I was involved in upgrading Quantitative Systems Pharmacology Work Bench (QSPWB), Seven Bridges, DNA Nexus, and Veeva Vault Regulatory Information Management System projects. Responsibilities: Authored/ reviewed SDLC deliverables (Quality Assurance Plan (QAP), System Document Index (SDI), User Requirements Specifications, Risk Assessments, Design and Configuration Specification, Development and Test Plan, Design/Code Review, Unit testing, System Integration Testing, Development Summary Report, Acceptance Test and Plan, Installation Qualification, User Acceptance Testing, Acceptance Test Summary Report, Requirement Traceability Matrix, Quality Assurance Summary Report, Release Authorization Notice, Business Continuity Plan, Disaster Recovery Plan, System Use SOP, System Admin SOP) upon request to ensure adherence to SDLC, policies and procedures, and system specific planning documents for GxP and non GxP systems. Partner with assigned Business Unit, Technical Unit including internal and external developers, Quality Unit, and testing representatives on project teams ensuring strategic approach is followed. Assisted Project manager in developing project schedule as it relates to required SDLC activities. Routed documents for review and approvals in MIDAS (an Electronic Document Management System) Supported Regulatory Risk assessments, IT Third party risk assessments and CMDB registration. Worked closely with Vendor to review the documentation provided by them. Authored and reviewed change control records in Remedy system. Involved in remediation activities, corrective, and preventative actions for internal assessments. Reviewed deliverables from Vendors (Veeva Systems) for COTS applications. Provided support with Go-live/Cut-over activities during system deployments. Validation Analyst Dec 2017 to May 2018 Allergan Pharmaceuticals, NJ As a Validation Analyst, I was involved in authoring/ reviewing various validation deliverables for Global TrackWise system. Responsibilities: Reviewed both pre- and post-execution IQ, OQ and PQ test scripts. Prepared Deviation Reports, Deviation Logs for the various errors occurred during the test execution. Authored Test summary reports to summarize the testing effort in QA environment. Developed Traceability Matrix to ensure all critical Requirements are tested in full within the Validation Test Scripts. Prepared Validation Summary Report (VSR) to summarize the overall validation effort. Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology. Coordinated with technical, business and QA teams for creating/investigating Deviations. Performed Gap Analysis and prepared Remediation plans to fix the gaps identified. Conducted trainings to the global business users and coordinated with them during UAT testing. Responsible for routing documents for review and approval using CORAL system. Worked on change control documentation such as Change Control forms, Change Assessments, Change Plans, Change summary memos. Involved in 21 CFR part 11 Assessments and Data Integrity assessments. Planned, Tracked and Communicated progress of assignments and milestones with IT and Business Teams. Sr. Validation Analyst/ QA Reviewer Jan 2017 to Dec 2017 Teva Pharmaceuticals, NJ The project involved in upgrading the Global Pharmacovigilance Safety Systems ArisG and DELTA V in compliance with FDA regulations and 21 CFR Part 11 and also worked on TrackWise systems. Responsibilities: Analyzed User and Functional Requirements for development of test scripts. Evaluated the testability of user requirement specification, functional requirement specification, and system design specification document for different functionalities in ARISg and DELTA V Reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) test protocols in accordance with GxP and FDA Regulations for new functionality and modifying existing test scripts. As part of the testing, performed Data Entry, Case Processing, Narratives, causality, generate reports and ensure that system is able to search, save the cases and push the cases to the next workflow as per user s requirement. Performed test script dry run executions in development environment of ARISg and DELTA V systems. Performed Risk assessment to determine the testing effort. Utilized HP-ALM for the creation and execution of OQ, PQ test scripts in QA environment. Executed the test cases stored in test plan, imported locally to the test lab in HP ALM. Logged defects in HP ALM defect module and worked closely with technical team to resolve them. Worked closely with Business Users and Technology Teams to identify the test scenarios and test cases. Worked with Project Manager to provide the daily status of validation activities and project plan to meet the Go-Live Validation Analyst Jul 2015 to Jan 2017 Allergan Pharmaceuticals, NJ The project involved in change control activities for various projects like TrackWise, Argus, and the HUB-Artwork Management System. Responsibilities: Authored documentation for all aspects of computer system validation lifecycle in accordance with FDA regulations including: Validation Protocols, Installation Qualification (IQ) specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification. Performed Risk assessment to analyze and quantify different risk areas in the system in collaboration with Business Unit, Technical Unit and Quality Unit teams. Developed Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases. Generated Validation Summary Report to summarize and document all validation activities. Authored end-to-end validation documentation for the HUB-Art Work management system to ensure compliance with company policies and procedures Supported in IQ, OQ, PQ executions, reviewed and maintained track of Defects associated with the scripts through Exception Reports. Authored Deliverables for development phase like development plan, development phase summary report (DPTS). Peer reviewed validation documentation in compliance with GDP and SOP's. Successfully led, delivered multiple simultaneous projects within tight deadlines. Validation & Verification Engineer Jan 2015 to Jun 2015 GE HealthCare, Wauwatosa, WI As a Validation & Verification Engineer I was involved in verifying software and hardware for a medical product used to diagnose and treat coronary heart disease and validating the software used in Invasive Cardiology (ECG) as per 21 CFR part 11 and 820 guidelines and GMP compliance. Responsibilities Authored and maintained overall Test Plans including a detailed description of the item being tested and its scope, user requirements, environmental needs, risk assessment and approach/methodology. Documented the results from Test Execution as Objective evidence for FDA Audits. Recorded software defects, reporting bugs, and assigning them to the concerned department/ person using ClearQuest. Developed IQ/OQ Test Scripts/Protocols and revised SOPs to address test requirement. Performed Gap analysis and successfully implemented Remediation plans to fix the gaps. Performed extensive and thorough GDP (Good documentation practices) on several verification documentations. Used IBM Doors to create, maintain, execute, and update user and design verification protocols. Working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems Created the SPRs (Software Problem Reports, Defects), Resolved the SPRs and Verified the SPRs in IBM Rational Clear Quest (A Defect Tracking Tool). Conducting remediation for the verification and validation results in order to make sure all the evidence are recorded and stored according to Good Documentation Practices. Performed Regression testing upon receiving new builds and updated the test cases according to the new build. Performed gap analysis and prepared the corresponding remediation plan to check for compliance. Conducted peer reviews for the reports generated by other Engineers and provides everyday status updates. Validation Analyst, Jun 2014-Jan 2015 McNeil Consumer Healthcare/ Johnson and Johnson Consumer Healthcare (J&J), PA Responsibilities: Authored/updated Validation Plan, Validation summary report, User Requirement Specification, RTM, and Test protocols. Authored/ assisted in Installation Qualification, Operation Qualification (OQ) and User Acceptance test scripts for Labware LIMS Performed Dry Runs to make sure system functionality is working as expected. Performed Executions in QA environment and wrote Test Incident Reports. Coordinated with the Quality Assurance department to ensure all Test Scripts were executed successfully in QA/Validation environment. Conducted execution walkthroughs to business users from a documentation perspective during UAT. Generated, tracked, and maintained Change Control procedures and Change Management as and when necessary. Validation Engineer Apr 2013-Jun 2014 Medtronic, NJ As a validation Analyst, involved in development of various CSV deliverables for Electronic Document Management System (EDMS) Responsibilities: Worked on the validation of EDMS and performed testing on the application for Edit Workflow, Obsolete Workflow and Superseded Workflow. Developed qualification protocols IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to support validation testing. Involved in data integrity, documenting audit findings and Audit Summary Report. Developed Training documentation and was involved in training/guiding business users on GDP and Test Execution practices during UAT s. Involved in reviewing existing validated documentation and evaluated executed change controls, reported problems in order to determine if any actions are required such as upgrading and replacement. 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