PROFESSIONAL SUMMARY:

• Around 7 years of diversified experience in Pharmaceutical, Biotechnology and Health Care industries with specialization in the areas of Computer System Validation (CSV) as a validation Analyst/Quality and Compliance Analyst/Technical Writer.

• Strong knowledge about Pharmaceutical/Medical device regulations like FDA: 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820 and involved in implementation of CFR Part 11 rules (Electronic Records, Electronic Signatures, Audit Trails and Security events).
• Extensive validating experience in FDA regulated environment and research laboratories with good understanding of cGxP (GMP, GDP, GCP and GLP) standards under the compliance of 21 CFR Part 11.
• Well acquainted with all phases of Software Development Life Cycle (SDLC) methodologies like Agile, Waterfall, V Model, and Spiral.
• Experience in developing and reviewingUser Requirement Specifications (URS), Functional Requirement Specifications (FRS), Soft Ware Design Specifications (SDS), and user manuals of allcomputerized systems and laboratory instrumentation.
• Hands on experience in writing documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Requirement Traceability Matrix (RTM) and Validation Summary reports (VSR).
• Experience in validating Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), Change Control Management System (CCMS), Data Migration and Adverse Event Reporting System (AERS), TrackWise Quality Control Management System (QCMS).
• Experience in designing Test Plan, Test design specification, Test Procedures, Test Cases, and Test Summary Reports.
• Experience in performing Gap Analysis, reviewing and performing Corrective, Preventive Actions (CAPA), and suggesting the Remediation Plans to mitigate the non - compliance.
• Experience in Reviewing/Writing/Updating current operating procedures and developing new Standard Operating Procedures (SOPs) and train users on SOPs.
• Proficient using Documentum and TrackWise softwares.
• Solid analytical skills and ability to do root cause analysis of situations with an in-depth evaluation of various factor

TECHNICAL SKILLS:

Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, LIMS

Testing Tools: HP Quality Center, HP ALM

SDLC: Waterfall, V-Model, Agile

Business tools: MS Office (Word, Excel, Power Point, Access, Visio), Argus Safety 6.0 and Documentum, SQL server 2012

PROFESSIONAL EXPERIENCE:

Confidential, Foster City, CA

Validation Analyst

Responsibilities:

• Involved in validation process of Infrastructure qualification project.
• Performed validation activities for GFAX system upgrade.
• Reviewed, updated and documented User and Business Requirements, DS and Functional Risk Assessment (FRA)
• Authored the Validation Plan for GFAX Project.
• Developed IQ/OQ test plans, traceability matrices, deviation forms and validation summary reports.
• Executed GFAX IQ/OQ test plans and test scripts, and responsible for approval of IQ, OQ protocol scripts.
• Recorded and reviewed the IQ/OQ execution process in Test and Production environment.
• Involving in Execution of the OQ Test Scripts and writing Deviation and Test Summary reports.
• Reviewed and modified existing Standard Operating Systems (SOPs) and authored the work Instructions.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Engaged in establishing standard quality andvalidationpractices
• Made sure all the documentation and records met 21 CFR Part 11 requirements.

Confidential, Atlanta, GA

Validation Analyst

Responsibilities:

• Involved in validation process of MES system upgrade.
• Performed validation activities in SCADA expansion Project.
• Reviewed, updated and documented URS,FRS
• Performed User and Business Requirements analysis to prepare Validation Plan
• Authored the Validation Plan for SCADA expansion Project.
• Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports.
• Executed SCADA IQ/OQ/PQ test plans and test scripts, and responsible for approval of IQ, OQ, and PQ protocol scripts.
• Recorded and reviewed the MES IOQ execution process in Test/QA and Production environment.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs under GxP regulated pharma environment.
• Involving in Execution of the OQ and PQ Test Scripts and writing Test Summary reports.

Confidential, Hayward, CA

Validation Analyst

Responsibilities:

• Involved in Validation activities for multiples releases within SAP ERP.
• Reviewed and edited the URS/FRS/DS documents of SAP.
• Developed Validation plans (VP) to define validation strategies for SAP including Infrastructure Qualification and deployment.
• Involved in validating the TrackWise CAPA (Corrective Action Preventive Action) Business Workflow
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Executed test cases to verify TrackWise functions, Workflow, Queries, Scope, End-End flow Approvals, permissions and Reports
• Reviewed and updated the URS/FRS/DS documents of SAP.
• Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports (VSR).
• Developed and executed IQ/OQ/PQ test plans and test scripts.
• Involved in Validation activities for releases within SAP.
• Involved in Data Migration End-to-End testing including executing the test procedure and writing the Test Analysis Report for Data Migration End-to-End System Test.
• Managed the testing process in Quality Center
• Ensured that application complies with 21 CFR Part 11 and cGxP regulations.

Confidential

Validation Analyst

Responsibilities:

• As a member of Computer Systems Validation team, responsible for documenting and reviewing all the validation deliverables.
• Performed regulatory and risk assessment of the computer systems.
• Used Documentum for storing the files.
• Authored VMP (Validation Master Plan) with risk based approach for validation.
• Responsible for developing, analyzing and reviewing validation deliverables like User Requirement specification and Functional Requirement Specifications.
• Responsibilities also include system qualification; assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts.
• Responsible to get QA approval for validation deliverables and Vendor Audit.
• Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.
• Assisted in documentation and development of SOPs.
• Designed, developed and implemented Test Plans using the detailed business requirements document.
• Maintained theTraceability Matrixbetween Requirements, Test cases and Defects.
• Extensively involved inDefect tracking,reviewingandanalyzing and reporting test result using HPALM.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in QC and reported the defects.
• Performed change control by assessing proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
• Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.
• Made sure all the documentation and records met 21 CFR Part 11 requirements.
• Submitting daily and weekly status reports to the manager and performed timely escalations to the management.

Confidential, Somerset, NJ

Validation Consultant

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Involved in validating the TrackWise CAPA (Corrective Action Preventive Action) Business Workflow.
• Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Executed test cases to verify TrackWise functions, Workflow, Queries, Scope, End-End flow Approvals, permissions and Reports.
• Developed the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document
• Developed Master Test Plan to strategize the testing approach.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort
• Involved in the execution of test data for Positive and Negative testing
• Responsible for the management of Deviation Handling documents.
• Followed good test practices to document the test evidence, Deviations, Resolutions, and Corrective Actions.
• Developed the test plans and test cases for Regression and Functional Testing
• Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 compliance

Confidential

Validation Analyst

Responsibilities:

• Authored SOPs & IQs, OQs, & PQs for validation.
• Participated in continuous quality assurance process improvements efforts.
• Developed, executed and maintained validation methodology in accordance with applicable regulatory requirements and industry best practices.
• Involved in precision inspection and explaining precautionary measures to workers.
• Written SOPs for test plan, test cases, and test procedure using business requirements document and functional requirements document of the system under company regulatory system.
• Compiled data and define changes required in testing equipment and testing procedures.
• Responsible for editing Requirement Traceability Matrix (RTM) document provided by Validation Specialists.
• Coordinated with vendor and technicians for device installation.
• Tested and analyzed the design to optimize the function, appearance, and manufacturing of new parts and assemblies.