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Computer System Validation Lead Resume

IllinoiS

EXPERIENCE SUMMARY:

  • Confidential has more than 14 years of experience in Life Sciences domain. He has excellent skills in Computer System Validation, Business Analysis, Functional Testing, Database Testing, Compliance and Team management.
  • He has sound knowledge and real - time experience on different software development life cycles that helped team to deliver critical application solutions to meet client expectation
  • Working to maintain GxP compliance for Confidential regulated environment. Computer Systems Validation (CSV), 21 CFR Part 11, GDP and in authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS) review and Functional Requirement Specifications (FRS) review and Requirement Trace Matrix (RTM)
  • Review and approve SOP”s, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Data Migration Protocols (DMP) and Validation / System Test Scripts
  • Define end to end SDLC validation methodology for computer systems based on regulatory & IT risk profiling. Expertise in GxP and 21CFR and its implications in computer system validation.
  • Perform Validation/Part 11 Assessments for new and existing computer systems.
  • Provide Quality oversight to complex qualification activities and projects including timely review and approval of project and process validation plans, protocols, summary reports and deviations to ensure project timelines are not impacted.
  • Good understanding on the Life Cycle of QA process in the validated environments and Proficient in Validation testing, Configuration Testing, Functionality testing, Database testing and Regression testing for various builds/ versions.
  • Provide QA review and guidance on change request in consultation with change request owners to evaluate validation impact in addition to Validation Plans, Risk and Impact Assessments as appropriate
  • Proven experience designing and implementing testing strategies, formal test plans and test cases to ensure the delivery of quality software applications
  • Involved in Audit preparation and ensures smooth audit completion and take necessary Corrective & Preventive Actions based on Audit findings.
  • Reviews/updates/assists in developing departmental standard operating procedures (SOPs).
  • Ensures that all activities are in compliance with cGMP, Health Authority regulations.
  • Engaged with project teams to identify Quality, Compliance issues, provide CAPA and track it down for closure.
  • Good Experience in Informatica - Information Life Cycle Management Data Archiving, Informatica Data Validation Option tool and Dynamic Data Masking
  • Good experience in creation of templates, Power Form links and Validation in DocuSign application.
  • Experience in API testing, Web Services, REST API using UFT and Post Man
  • Good experience HP Quality center, in Requirements, Test Plan, Test Lab and Defects Modules.
  • Strong project management experience in defining and initiating projects, assign testers, scheduling tasks and monitoring performance of component projects to ensure the ultimate success and acceptance of the program.
  • Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards.
  • Work with leadership team for Forecasting, Utilization, Client Profit, and articulate test efficiencies and cost savings.

TECHNICAL SKILLS:

IT Quality Compliance: 21 CFR Part 11, GAMP good practice guide, Risk Based Validation Internal Quality Audit, Validation Risk Assessment and Project Compliance health check monitoring

Testing: Manual, Validation, Dataware house, IT Quality and Compliance (Technical Assurance) and DB Testing

Clinical Trails tools: InForm, Rave and Oracle Interactive Response Technology (IRT). TDM (Test Data Management) Bugzilla, HP Quality Center v.10,UFT,Microsoft Viso, Post Man, DocuSign and ICompare

Hardware / Platforms: Windows 98/XP/2000/Windows 7.

Databases: SQL Server & Oracle

Configuration Management Tools: MS Visual Source Safe, EDMS, First Doc 6.1, ServiceNow and Doc Compliance 4.01

Data warehousing Tool: Informatica Power Center Designer, Data Validation Option (DVO), Enterprise Data Manager (EDM) and Dynamic Data Masking tool

PROFESSIONAL EXPERIENCE:

Confidential, Illinois

Computer System Validation Lead

Environment: Informatica Power Center Designer, Data Validation Option (DVO), Enterprise Data Manager (EDM),Dynamic Data Masking (DDM) and HP Quality Center

Responsibilities:

  • Playing the role Validation Lead and Onsite Coordinator for testing team of 4 persons including mentoring, managing workload priorities, providing technical and functional knowledge.
  • Authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS) review and Functional Requirement Specifications (FRS) review and Requirement Trace Matrix (RTM)
  • Review and approve Validation / System Test protocols.
  • Involved in writing, review and execution of Validation Protocols in HP Quality Center (QC).
  • Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
  • Provide quality oversight to complex qualification activities and projects including timely review and approval of project and process validation plans, protocols, summary reports and deviations to ensure project timelines are not impacted
  • Maintaining all the Validation package documents in ADAM (Document Management System)
  • Creation of DIET (Defects, Incidents, Enhancements Tracker) cases and track it till closure
  • UAT Coordination with Business Users
  • Reviews/updates/assists in developing departmental standard operating procedures (SOPs).
  • Performed Data Validation using Informatica Power Center Designer and Data Validation Option (DVO) for the systems Archived in Confidential (Information Life Cycle Management).
  • Verify the Legal Holds, Retention Policy and Data Masking using Informatica SQL Worksheet.
  • Tracking the Defects in HP QC by Raising an IR and track it till close the issue.
  • Sharing Weekly status Report with client on project status.
  • Training the team members in the application and proctoring them.

Confidential, New Jersey

IT Quality and Compliance Lead

Environment: Inform, Central Designer, First Doc, Quality Center v.10 and ALM v.11

Responsibilities:

  • Follow Confidential 's Validation Process Create/Review/Approve Validation documents from Initiative through Certification Summary (including but not limited to: Initiative, Project Plan, Val Plan, Protocols, Trace Matrix, ISSD, Cert Summary, Test Plan, Test Summary, IR, Release Notes)
  • Provide an independent review of the project deliverables to ensure they meet regulatory expectations and standards and provide approval to designated deliverables
  • Ensuring deliverable are meeting quality gate requirements, thereby ensuring sequential execution of SDLC processes.
  • Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
  • Review and approve Validation / System Test protocols in HP Quality Center (QC).
  • Participate in requirements walkthrough
  • Maintaining all the Validation package documents in First Doc (Document Management System)
  • Provide technical input in determining strategy for validation activities
  • UAT Coordination with Business Users
  • Lead the IR process until all issues are resolved and documentation complete
  • Manage external contractors, and third party vendors for validation projects
  • Provided inputs to arrive at an end-to-end test strategy for several large programs that connect multiple systems across divisions.
  • Suggesting and contributing for process improvements as appropriate

Confidential

QA Lead

Environment: IRT (Interactive Response Technology), SQL Server 2008 and Bugzilla

Responsibilities:

  • Played the role of Offshore Test Lead in a team of 1 Onsite and 20 Offshore team members
  • Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards. Effort Estimation and team management
  • Define and track quality assurance metrics such as defects, defect counts, test results, and test status
  • Lead and conduct application regression scripts to be executed and identifying post-production defects
  • Provide knowledge transition to the team and allocate the tasks
  • Prepare Validation / Test plan and followed the timelines to complete each release of IRT projects
  • Reviewed the Test Deliverables of the team and delivered quality products
  • Monitor and control the test progress in line with the Test Plan
  • Coordinate telecalls, attended daily status calls with Deliveries and Business Analyst
  • Worked with senior management by involving new project proposals and estimations
  • Coordinate end-to-end testing with external channel/domain QA teams
  • Ensure compliance with testing best practices and standards
  • Involved in review, Pre-approval and Post approval for all the System test cases.
  • Performed defect leakage and route cause analysis

Confidential, Maryland

Validation Engineer & Onsite Coordinator

Environment: Confidential 4.01

Responsibilities:

  • Onsite Coordinator.
  • Involved in writing, review, execution, proctor of IQ, OQ, PQ and Configuration Scripts.
  • Involved in providing templates, routing protocols, and review and approve for specification documents.
  • Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
  • Maintaining all the Validation package documents in Confidential (Document Management System)
  • Creation of (Defects, Incidents, Enhancements Tracker) cases and track it till closure
  • UAT Coordination with Business Users
  • Involved in preparing RTM for the project.
  • Training the team members in Confidential 4.01.
  • Ensures the project team follows the Computerized Systems Life Cycle Process and Computer System Validation process throughout the project life cycle.

Confidential

QA Lead

Environment: ASP, Inform 4.5 and SAS Data sets

Responsibilities:

  • Played the role of Offshore Test Lead in a team of 1 Onsite and 18 Offshore team members
  • Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards.Effort Estimation and team management
  • Define and track quality assurance metrics such as defects, defect counts, test results, and test status
  • Provide knowledge transition to the team and allocate the tasks
  • Prepare Test plan and followed the timelines to complete each release of Clinical Trail projects
  • Reviewed the Test Deliverables of the team and delivered quality products
  • Monitor and control the test progress in line with the Test Plan
  • Coordinate end-to-end testing with external channel/domain QA teams
  • Ensure compliance with testing best practices and standards
  • Coordinate telecalls, attended daily status calls with Deliveries and Business Analyst
  • Collecting and Collating Metrics
  • Performed defect leakage and route cause analysis

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