SUMMARY

• Having 12 years of experience in Sr. Validation Analyst with strong background in Computer System Validation, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part 11,210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP).
• Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy.
• Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
• Expertise in creating and executing Computer System Validation Plans, SOP’s, protocols and validation test scripts and document test results in accordance with FDA standards.
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations.
• Experience in Automotive embedded domain and Automotive Infotainment Verification/validationexperience working with Tier1 supplier and Engineering service providers
• Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Hands on experience in Design History Files (DHF). Performed Design of Experiments (DOE). Orchestrated and time-lined engineering studies and other experiments. Created Risk Management Plan and executed it. Reviewed Risk Management Documentation and well versed in FMEA and FTA Analysis. Lead various PFMEA and DFMEA efforts.
• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Experience in using quality center to manage testing artifacts.
• Performed GAP analysis in identifying compliance gaps.
• Developed and implemented corrective action and preventive action plans (CAPA).
• Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Excellent knowledge and experience in configuring and validating StarLIMS, SQL *LIMS
• Developed interfaces with laboratory instruments using StarLIMS Scripting Language
• Performed various types of testing like Black box, Performance and UAT testing.
• Expertise in writing and reviewing the validation deliverables.
• Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Excellent verbal, documentation and organizational skills.
• Strong hands on experience in using Win Runner, Load Runner and Test director.
• Ability to work both independently and in a team-oriented working environment.

TECHNICAL SKILLS

Tools: Quality Center, MS Office Suite Word, Excel, PowerPoint, Outlook, MS Visio, MS Project.

Operating System: Windows XP/Vista

Methodologies: Waterfall, V-Model, Spiral, and Agile.

FDA Regulations: 21CFR Part 11 (Electronic Records, Signatures) (cGMP’s), 803 (Medical Device Reporting), 820 (Quality System Regulation).

Validation Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report.

Laboratory Equipments: Gas chromatography/Mass chromatography (GC/MS), Liquid chromatography(LS), Scanning Electron Microscope.

PROFESSIONAL EXPERIENCE

Confidential, Vernon Hills, IL

Sr. Validation Analyst

Responsibilities:

• Responsible for writing Validation Plan.
• Used Lab ware LIMS application which has modules like sample testing, assigning new tests, entering results and reviewing result data.
• Used MS Visio to document workflow and flow diagrams for design business process. Used MS Project for planning and scheduling project activities.
• Responsible for authoring, performing and/or approving qualification and validation documentation such as System Design Requirement Specifications (SDRS), Change Control, Document Change Notice (DCN), Non Conformance Reporting (NCR), GAP Analyses, CAPA, Process Failure Mode and Effect Analyses (PFMEA's), Engineering Studies (ES),Process Verification and Qualification, Design History Records (DHR), Protocols, SOPs and Test Methods.
• Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Responsible to support manufacturing and engineering department for product operation, equipment and process validation and qualification (FMEA, IQ/OQ/PQ).
• Updated the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution.
• Prepare / review risk management plans on the products / validation to ensure necessary assessments, measures are taken through FMEA & FTA, risk-based approach on the URS / FS.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules.
• Validated test methods and analyzed the data using Gage R&R and Anova studies.
• Involved in project Management and Team building activities e.g. taking minutes of meeting and following up with team members to get the job done as discussed on time and scheduling other meeting as per project needs.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Retrospective Validation of Trial Finder. Involved in performing the GAP Analysis of the system. Developed Risk Assessment and Deviation Report.
• Created documents such as FMEA, MVP, TMV, IQ, OQ, PQ etc.
• 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.
• Responsible for creating test cases for Installation and Operational Qualification (IQ/OQ) of the application.
• Used Test Director for bug tracking, reporting and following up with development team.

Confidential, Greenville, NC

LIMS Validation(Analyst)

Responsibilities:

• Involved in the calibration of HPLC and GC, and checked its accuracy, detection limits, noise level, precision, reproducibility, repeatability and robustness.
• Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
• Managed packaging validation projects on sterile packaging and pre-sterile packaging processes
• Created templates for method validation protocol, method validation report, standard test method.
• Created or reviewed PFMEA, IQ/OQ/PQ/PPQ protocols and reports, analyzed test results, communicated findings and got approvals across all functional teams involved.
• Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
• Prepared documents for Test cases for Integration, Functional Testing and User Acceptance Testing using Quality Center tool.
• Reviewed and drafted Standard Operating Procedures (SOPs) and User Manuals for the equipment's and associated software to ensure they meet FDA requirements.
• Maintained Requirement Traceability Matrix (RTM) to track requirements.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
• Reviewed and carried out UAT, Positive testing, Negative testing, Regression testing for the Chemstation software.
• Used quality tool to define the manage risk or product failure (FMEA, FTA, Fish Bone diagram).
• Experienced in in statistical data analysis using Minitab (Gage R&R, Anova studies) and Distribution Analyzer
• Also performed non- functional testing like Performance Testing, Stress Testing, and Documentation Testing for the software's.
• Processed FMEAs, corrective actions and customer quality concerns.
• Involved in the validation of equipment and software associated with the Process Validation for manufacture of small volume Parenteral and automated filling.
• Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.
• Monitored the dry runs for the labstation module and changed test scripts accordingly for the events generated.

Confidential, Malvern, PA

Validation Analyst

Responsibilities:

• Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.
• Change control Procedure and Testing SOP’s.
• Validation initiative included Failure Mode Effects Analysis FMEA to validate process design; Design of Experiments DOE ; Statistical Process Control SPC ; and tolerance analysis for full process capability analyses.
• Gathered User Requirements from Business process owners.
• Reviewed URS (User Requirements Specification).
• Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification) documents.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with 21 CFR Part 11 and GxP FDA Compliance Regulations.
• Developed Test Plans, Test Cases using HP Quality Center.
• Was responsible for reviewing Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) test scripts.
• Coordinated UAT (User Acceptance Testing) for the application.
• Reviewed the Requirement Traceability Matrix (RTM).
• Was involved in reviewing Test Cases, Test Scripts and Test Summary Reports.
• Worked on Risk Assessment of the systems.
• Involved in deficiency investigations.
• Using quality tool to define the manage risk or product failure (FMEA, FTA, Fish Bone diagram).
• Reviewed and approved Equipment/Process documentation including: Process FMEAs, Engineering Studies, Installation Qualifications, Operational Qualifications, and Performance Qualifications.
• Reviewed the Vendor Assessment Reports.
• Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Test Cases for Functional and Regression Testing.
• Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.
• Reviewed protocols for Audit Trail, time stamp and electronic signature for workflow of documents.
• Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.

Confidential, Annandale, NJ

Validation Analyst

Responsibilities:

• Analyzed user requirements document, system specification document.
• Developed, implemented and executed test methodologies and plans to ensure software product quality.
• Created test plan and detailed test cases using Quality center.
• Tracked changes made to the requirements, tests and defects using Quality center.
• Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements.
• Worked on Traceability Matrix
• Created and reviewed IQ, OQ, PQ protocols, Master Validation Plan.
• Automated Test scenarios for GUI, Functionality, Boundary, Security and Regression Testing.
• Performed Data Migration Policy.
• Coordinate the activities in the SDLC with focus on the system analysis and maintenance activities.
• Technical involvement with projects, support during audits, and collaboration with the vendors.
• Wrote and executed test cases to validate user requirements and exercise all system functions
• Provided a Validation strategy documents which involved project overview, development approach, roles and responsibilities, validation approach and deliverables.