SUMMARY

• Having 8 years of experience as Validation Specialist/Validation Engineer/ Business Analyst/ Technical Writer, Medical Devices, Test Analyst.
• Demonstrated experience in Computer System Validation and Business Analysis.
• Specific expertise in developing validation documents in accordance with SDLC and company SOPs.
• Developed validation documents for SAP ECC 6.0 (Order to Cash, Finance, and Manufacturing), Laboratory Information Management System (LIMS), Track Wise, Electronic Document Management System (Documentum) and Excel Spreadsheets in accordance with 21 CFR Part 11& GxP regulations.
• Specialist in developing all of the following validation deliverables - Regulatory Assessments, Risk Assessments, Validation Plans, 21 CFR Part 11 Assessments, Remediation Plans, Qualification Plans, Trace Matrices, IQ/OQ/PQ Test protocols and scripts, Qualification Reports, Deviation /Incident Reports, Problem Reports, Change Controls, Addendums and Validation Summary Reports.
• Experience as IT Business Analyst in conducting meetings with Business Users and collect user requirements.
• Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulations.
• Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Proficient in developing Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Skilled in leveraging gap analysis techniques to develop Remediation Plans for retrospectively validating Computer Systems.
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC) methodology.
• Experience in developing Data Migration plans, requirement specifications, test cases and summary reports.
• Good understanding and implementation knowledge of Good Testing Practices.
• Expert in using risk based approaches for validating computer systems.
• Good understanding of Sarbanes Oxley Regulation (SOX), Sunshine act, Information Technology Infrastructure Library (IT-IL) guidelines.
• Proven track record of working for extensive hours in crunch project situations.
• Great team leader and exceptional time management skills.
• Excellent interpersonal dexterity with proven ability to converse, liaise, negotiate and relate with a wide range of personalities from diverse socio-economic and cultural backgrounds.

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

SDLC: Waterfall, V-Model, Agile

Testing Tools: HP Quality Center

Business tools: MS Office (Word, Excel, Power Point, Access, Visio), TrackWise, Siebel CRM, Argus Safety, IRMS and Documentum

Operating Systems: Windows NT/95/98/2000/XP/Vista/7, UNIX, Linux, Macintosh

PROFESSIONAL EXPERIENCE

Confidential, West Valley City, UT

Sr. Validation Analyst/Technical Writer

Responsibilities:

• Customized and validated different components of the LIMS modules.
• Acquired and documented the business requirements.
• Prepared Validation Master Plan (VMP) for validating LIMS.
• Performed Computer System Validation Assessment for Lab ware LIMS system to identify the validation deliverables for the project implementation regarding Documentum.
• Expertly employed Documentum, which is a computer software document management system for tracking and storing of electronic documents like electronic records, quality assurance, scientific and research reports, and SOPs.
• Assisted in documentation and development of SOPs for Track Wise.
• Extensively used Track Wise system to comply with documentation review and approval procedures.
• Developed Validation test strategies, IQ’s for installation of the TrackWise software and OQ’s for testing the application functionality
• Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification.
• Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
• Drafted IQ test cases for verifying configuration of Track Wise workflows.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.
• Generated Validation Summary Report to summarize and document all validation activities
• Developed and reviewed Standard Operating Procedures (SOPs), Requirement Traceability Matrix and Work Instruction for various functionalities of the system.
• Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
• Performed user acceptance testing to the check the various functionalities of LIMS.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Conducted GAP analysis and prepared Remediation Plan.
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Confidential, North Wales, NJ

Sr. Validation Specialist

Responsibilities:

• Performed end to end validation on different tools used in Medical Device development on time and within the allotted budget.
• Validated tools including Document Management Systems, Signal Processing Tools, Circuit Design Tools, Code Compiling Tools, Defect Tracking Tools used in Medical Device Development.
• Documented the User Requirement specifications and Design Specifications for all the tools used in the development of Medical Devices.
• Performed Risk Assessment for different tools following GAMP5 procedures.
• Performed configuration of workflows for a project by defining the activities and also tested the configured product.
• Used HP Quality Center for bug tracking, reporting and following up with development team.
• Involved in validation effort for Siebel Complaint & Recall Management System (CRMS), including developing Validation Plan (VP) and Validation Summary Report (VSR).
• Involved in reviewing Requirement Specifications and Design Specifications for Siebel CRMS application.
• Involved in User meetings, Design sessions to capture the System Requirements and documented in System Requirement Specification (SRS) including interface requirements with other systems.
• Validated Siebel CRMS application, which helps the company to enhance the business process and utilize compliant collection and service management.
• Wrote and reviewed the system related SOPs to ensure compliance of company’s processes, policies, and Procedures.
• Wrote the Validation Assessment for the management to provide them a brief review of objectives to be covered during validation.
• Partnered with Quality Assurance personnel to review and approve validation deliverables.
• Validated CRMS in accordance with 21 CFR Part 11 and GMP regulations.
• Prepared/Executed IQ, OQ, PQ/UAT Test Plans, Test Scripts and Test Summary Reports.
• Prepared validation documents for Integration Testing (Dry-Runs), System testing and User Acceptance Testing for Siebel CRMS system.
• Validated the review, escalate and approval process for investigations and verifications.
• Created test scripts for end to end scenarios for complaint creation, review, investigation and closure of investigation in Siebel CRMS system.
• Involved in Change Control Processes to keep track of all the changes made to the validated environment.
• Prepared Deviation Reports, Deviation Logs for the various errors occurred during the testing phase of SDLC.
• Developed Validation Summary Report (VSR) to summarize all the validation activities performed during the project implementation.

Validation Analyst/Tester

Responsibilities:

• Prepared Validation Strategy Document (VSD) to define the strategy of validation for SAP ECC 6.0 system (Manufacturing, Order to Cash, Master Data, and Finance) and its interfaces for Canada and Asia-Pac roll out implementations.
• Created the Master Test Plan that defines the test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Reviewed and approved URS, FRS and Functional Specs as Quality, Regulatory and Compliance consultant.
• Developed Operational Qualification (OQ) Test Plan and test scripts for SAP ECC implementation using HP Quality Center.
• Reviewed and approved OQ and UAT test scripts prior to execution as well as post execution to meet Good Documentation Practices and Test guidelines.
• Validated Excel Spreadsheets which are used in laboratories.
• Assisted Business Analyst in the assessment and gathering of supporting documentation, such As Test Method SOPs, Material Specifications, Test Data Sheets and Reports etc.
• Reviewed and tracked deviation reports where needed.
• Initiated the draft of Validation Plan detailing the validation deliverables and responsibilities of the team members.
• Good knowledge in determining and authoring CAPA (Corrective and Preventive Action) for system discrepancies/ non-conformances, Performing GAP Analysis and Remediation plans.
• Worked with development team to resolve the deviations detected in OQ test phase.
• Extensively involved inDefect tracking,reviewingandanalyzing using HP Quality Center.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Developed Test Summary Report and Validation Summary Report.

Confidential, PA

Validation Analyst/Technical writer

Responsibilities:

• Requirements Gathering, Documentation and Analysis.
• Closely interacted with designers/architects and software developers and prepared the Design Specification (DS) document.
• Involved in validating the application, along with the Compliance team, according to CFR Part 11 requirements.
• Followed the System Development Life Cycle in all stages of the project to develop validation deliverables.
• Created the Master Test Plan that defines the test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Wrote the Test Scripts and analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Involved in the execution of IQ/OQ protocol to complete the gaps in vendor protocol and documented the deviations.
• Worked with LIMS functional team to validate the specifications to be complaint with 21 CFR Part 11 and GMP regulations.
• Prepared Deviation Reports, Deviation Logs for the various errors occurred during the testing phase of SDLC.
• Wrote the OQ and PQ Test Scripts to check if it has covered the testing of all dashboards, standard and custom reports.
• Developed data migration plan which includes migration of all the open/closed change GxP tickets, open/closed change non-GxP tickets, open/closed Incident tickets.

Confidential

Process Validation Engineer

Responsibilities:

• Developed validation protocols and generated amendments to the protocols as required.
• Documented deviations that occurred during the protocol execution.
• Verified the calibration and maintenance status of the equipment.
• Scheduled validation activities and trained production operators.
• Monitored critical steps in the manufacturing process.
• Assured that approved testing standards are being used.
• Provided operational oversight to ensure the experimental execution and process technology transfers are delivered with right first time quality.
• Developed reports, batch records, procedures, risk assessments and project schedules to ensure successful project execution.
• Applied principles of cGMP, GAMP as related to process design.
• Trouble shoot equipment problems, identified the need for new equipment and made modifications to the existing equipment to optimize throughput and reduce process cycle time.
• Evaluated all the test results and generated a validation report.

Confidential

Validation Analyst

Responsibilities:

• Involved in different lab system validation activities including HPLC, Chromatography and Lab Instruments according to GxP and Part 11 requirements.
• Conducted interviews with users and documented requirement specifications with complete understanding of business process.
• Experience in writing design specs and configuration specs.
• Drafted and performed qualification protocols like IQ/OQ. Written supporting documents like security plan, system admin and support, role and responsibilities.
• Involved in system testing and user acceptance testing.
• Support the instruments and applications through change control process.
• Arranged meetings with Functional users in order to collect/document User Requirements and prepared Functional Requirements for the lab systems.
• Studied the data structure and other components of various lab application, conducted interviews with users.
• Responsible for taking samples and swabbing of Clean Equipment.
• Generated Product and Equipment Matrix for small utensil Equipment.
• Generated and Executed Cleaning Validation Protocol and Reports.