SUMMARY:

• Over 7+ years of experience in Life Sciences Industry as Computer Systems Validation Specialist
• Excellent documentation, review and approvals skills in compliance with Validation Practices and Good Documentation Practices (GDP).
• Strong knowledge of Pharmaceutical/Medical device regulations of FDA - 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820.
• Excellent experience in Cloud (SaaS) based applications
• Excellent experience in implementing Lab systems such as LIMS
• Excellent experience in implementing SaaS applications such as Veeva Vault, EtQ Reliance
• Strong knowledge and experience in GxP suites: GLP, GMP, GCP, and GAMP (4&5).
• Strong knowledge and background of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC).
• Familiar with Waterfall, Agile, Spiral, and V-model.
• Participated as assigned Validation Analyst on project teams to design, implement and validate enterprise class GxP computerized and lab systems.
• Experience in authoring, reviewing and approving Assurance Plans, Validation Master Plan (VMP), Business/User Requirement Specification (BRS/URS), Design Specifications (DS), Functional Requirement Specification (FRS), Requirements Traceability Matrix (RTM), and Validation Summary Reports (VSR).
• Extensive experience in documenting, reviewing and approving Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol, and Standard Operating Procedures (SOPs).
• Extensive Testing experience demonstrated in developing, reviewing and approving and documenting Test Plan, Test Cases, Deviations, Change Controls, and Test Summary Reports.
• Experience in performing Gap Analysis, reviewing and performing Corrective and Preventive Action (CAPA), and suggesting Remediation Plan to mitigate non-compliance.
• Thorough knowledge of Change Control Management Activities, Back-up and Structured Change Control Procedures.
• Knowledge and experience with automated testing tools - Quality Center.
• Experience in Remediation Activities from Remediation plan to Remediation Summary Report.
• Expertise in using Documentum and SharePoint.
• Experience in dealing with test scenario creation, test strategy creation, test data planning & creation, test case creation, test case dry runs, test case execution, defect management and test case and defect closures.
• Excellent organizational, interpersonal, problem solving, technical writing, and oral communication skills.
• Result oriented with focus and attention to detail.
• Proficient in working individually and as part of a team.
• Good at quickly comprehending new skills and applying them efficiently.

PROFESSIONAL EXPERIENCE:

Confidential, San Clemente, CA

Sr. CSV Engineer

Responsibilities:

• Involved in the computer system validation to develop IQ, OQ, PQ specifications for Veeva Vault
• Authored Test scenarios for EDMS, CTMS and ETMF in Veeva Vault
• Responsible for performing OQ execution on Site Management and Issue Management
• Documented and reviewed Test Strategy and Plan in execution of Operational and Performance protocols
• Documented and reviewed the following documents: Validation Plan, User Requirements, Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records for Corrective Action and Preventive Action (CAPA) and Change Control Management (CCM).
• Documented Installation Qualification (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) Protocols in person, with team and with third party implementors.
• Maintained the Requirements Traceability Matrix (RTM).
• Supported the annual product review, process scale up, continual process improvements utilizing the change control process.
• Responsible for documenting and reviewing quality procedures, work instructions, installation, operational and process (IQ, OQ & PQ) validation protocols and plans, ensuring regulatory compliance with cGMPs of all medical device regulatory agencies (i.e. FDA and ISO)
• Involved in retesting defects with the release of every new version of software development.
• Collaborated with cross functional team to develop validation protocols and reports while managing the execution of risk analyses utilizing process and design FMEAs and Master Validation
• Participated in Business meetings representing IT QA Department.
• Involved in validation testing on the application in accordance with 21 CFR Part 11.
• Tracked and monitored review and approval of validation deliverables, and participate in meetings with project team and Client Stakeholders as required;
• Designed and Developed process improvement tools for the Spreadsheet Validation Team.
• Managed a project restructuring the spreadsheet validation process and team.
• Validated spreadsheets used for regulatory, financial, and board reporting.

Environment: Veeva Vault (cloud-based SaaS), LIMS, Empower, ELN, MES Systems, ERP

Confidential, CA

CSV Analyst

Responsibilities:

• Responsible for implementing Systems Development Life Cycle in compliance to company’s procedures.
• Participated in Business workshops and helped business understand the importance of Good Documentation Practices.
• Performed Risk Assessments including 21 CFR Part 11 Assessment, GxP Risk Assessment, Supplier Risk Assessment.
• Participated in Change Management Meeting representing Validation Department.
• Analyzed system requirements and documented Test Plans, Test Scripts according to the system requirements.
• Documented SDLC Validation deliverables including but not limited to Assurance Plans, User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) protocols, Requirements Traceability Matrices (RTM) and Validation Summary Reports.
• Documented and updated Test Plans and Test Strategies.
• Involved in developing the application landscapes and define Test Strategies for the execution activities.
• Initiated and controlled the CAPA activities during Testing activities.
• Documented Remediation Plans and Validation Strategies.
• Documented Remediation Summary Reports.
• Trained IT and Business on execution activities.
• Documented Defect Tracker and maintained it till the closure of defects.
• Documented the Requirements Traceability Matrix (RTM) in support of Validation.
• Performed Regulatory Assessment and Risk Assessment for the Computer Systems.
• Performed GAP analysis, developed Remediation plans.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) Protocols in person, with team and with third party implementors.

Environment: LIMS, Empower, ERP, EtQ Reliance (SaaS), MDM Project.

Confidential, MA

CSV Analyst

Responsibilities:

• Facilitated the Project from Quality standpoint.
• Documented the following documents: Validation Plan, User Requirements, Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records for Corrective Action and Preventive Action (CAPA) and Change Control Management (CCM).
• Participated in Business meetings representing Quality Department.
• Documented the validation templates like Regulatory Assessment, Requirement Specs, Business Process flows, Validation Plan, Training Plan, Issues Log, Risk Assessment, Incident Reports, Problem Reports, Change Controls, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Trace Matrix, and Validation report.
• Documented Validation Plan and Master Test Plans to strategize the validation approach as well as test approach in various test cycles.
• Documented Functional Specifications, Technical Specifications and Design Specifications
• Defined validation approach for the custom components, interfaces, and Crystal reports.
• Documented Requirements Traceability Matrix (RTM).
• Maintained Training Logs and Incident/ Test Case Assignment logs.
• Trained the Business Users on Systems validation.
• Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance for various ongoing projects and authored the Systems validation Risk Assessments.
• Partnered with QA team to review and approve validation deliverables.
• Documented Deviation Reports, Deviation Logs for the various errors occurred during the testing phase of SDLC.
• Initiated the CAPA plans and monitored them through their lifecycle.

Environment: Lab Systems Implementations, ERP Interface remediation.

Confidential, PA

Validation Analyst

Responsibilities:

• Involved in preparing documentation for all aspects of the computer system validation life cycle in accordance with 21 CFR Part 11.
• Validated Enterprise Resource Planning (ERP): SAP ECC 6.0 Order to Cash, Manufacturing, Supply Chain Management and Service Management.
• Performed Remediation activities for the gaps encountered in periodic review.
• Hands on experience on HPQC, tracking tool.
• Well-rehearsed with QC application modules and worked on ERP Validated SAP project in manufacturing stream.
• Created and reviewed Process flow diagrams, Business Integrated Model (BIM), Business Process Master List (BPML), Verification Strategy document (VSD), RTM for the projects
• Designed and authored Standard Operating Procedures (SOP’s) based on the business requirements gathered for Validation Master Plan (VMP) and Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Work closely with BA team and Involved in analyzing the business requirements to develop the process flow diagrams.
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.
• Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are catered by the application.
• Validated the Electronic Records and Electronic Signatures in accordance with the FDA guidelines.
• Worked on co-ordination simultaneously with the QA department and executed the tests developed.
• Validated computer system and documented all the materials during the testing phase of the project.

Environment: SAP Upgrade, SAP Migration

Confidential

Validation/Test Analyst

Responsibilities:

• Performed Validation Testing on the application in accordance with 21 CFR Part 11.
• Implemented and developed a standard process for using Electronic Signatures on all electronic-document transfers using the 21 CFR part 11 standards.
• Maintained existing System & Integration Test Plan according to the Standard Operating Procedures (SOPs) and VSD.
• Involved in evaluating the 21CFR part 11 requirements and creating a check matrix for the same.
• Developed Master Test Plan and Summary Reports for LIMS Implementation.
• Assisted the cGMP Validation group in the development of GMP Quality Systems including Standard Operating Procedures (SOPs), batch records, change controls, Re-Validation, documents management, complaints management, and annual product reviews.
• Responsible for writing SOPs, IQ/OQ/PQs for the LIMS application.
• Performed Validation Testing on the application in accordance with 21 CFR Part 11.
• Drafting of new Corporate Level Standard Operating Procedures (SOP's) to govern all aspects of this system
• Validating processes in cGMP environment as per FDA guidelines
• Performed testing according to SOP’S, assured Process Validation, Cleaning Validation in compliance with cGXP’s (cGMP and GLP)
• Wrote the IQ & OQ Test Scripts
• Created and executed Test scripts for system validation and helped in UAT.
• Developed Test Matrix on the monthly basis for higher management and officials.

Environment: LIMS