SUMMARY

• Diversified experience as Validation Specialist/ Quality Analyst/ Compliance Analyst with proficiency in Validation protocols, Technical writing, Computer System Validation, 21CFR part 11 compliance and Quality Assurance in FDA regulated environments.
• Excellent knowledge of Software Development Life Cycle (SDLC), Software Quality Assurance (SQA) and Software Validation Life Cycle (SVLC).
• Good working experience in Computer Systems Validations (CSV) in compliance with FDA and MHRA regulations like 21 CFR Part 11, Part 820, 210, 211, and 58.
• Sound understanding of cGXP (cGMP, cGLP, cGCP) standards and GDP.
• Involved in writing Validation Protocols, Installation Qualification (IQ) specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification, Standard Operating Procedures (SOPs).
• Reviewed, approved and developed VMP, DS, URS - FRS, SCS, UTR, UAT, Test Plan, Test Scripts, CSV Risk Assessment and VSR.
• Deep understanding of various types of testing: End-to-End testing, Load and stress testing, Performance and latency (server and network) testing, Positive testing, Negative testing, User Acceptance Testing and testing using manual and automated tools.
• Proficient in conducting Unit, GUI, Functional, Integration, System, Performance and Regression testing on the applications.
• Experience in documenting Requirement Traceability Matrix (RTM), Data Migration Plans, Periodic Review, GAP Analysis, Risk analysis, CAPAs and Remediation Process.
• Excellent problem solving skills, quick learner and capability to perform well under pressure. Possess excellent documentation skills with good structured writing.

PROFESSIONAL EXPERIENCE

Confidential, Raritan, NJ

Validation Lead

Responsibilities:

• Review and Validate strategies/processes used in virtualization
• Identify and review deliverables used to validate the correctness of virtualization processes done either through the use of software applications such as vConverter, Double Take etc., or through source codes
• Review of Change controls and their evidences post implementation to verify successful migrations to Virtual machines
• Prepare and render CI Summary reports and co-ordinate with tech writers for getting them approved
• Prepare and maintain Test Summary reports and Protocol Summary reports used to govern the Virtualization processes until proper SOPs/WIs were developed
• Track all the Change controls and related metrics used to identify and distribute workloads within the team so as to complete the reviews in a timely manner
• Review migration protocols and migration scripts and co-ordinate with the core compliance team and technical team for closure of any defects/errors found
• Co-ordinate with various platform team to ensure migrations complete on schedule
• Raise and close IRIS/DARL tickets to account for all the work done by the QCSV team, the metrics of which were used to showcase the accomplishment of Compliance team to upper management.
• Co-ordinate with local compliance team located at ASPAC, EMEA and NA to develop validation strategy and identify scopes for different teams involved.
• Co-ordinate with project management team, technical team and local compliance team to develop Validation documents such as Compliance Plan, Migration Protocol, Migration Report etc.,
• Assist Testing team to implement HPALM for testing and provide them detailed walkthroughs on how to execute Migration scripts instead of the PDF scripts which are time consuming and cumbersome.
• Aid the project management team to assign required trainings to signatories and users of compliance tools such as EDMS, HPALM, JIRA etc.,
• At the time of actual migration/virtualization, review migration scripts post-virtualization, pro-actively co-ordinate with local testers and compliance team in order to close out defects if any and complete migrations within the allocated change window.
• Engage with the technical team to clearly understand the SDDC migration process in order to determine the impact of migration on the module and determine the level of testing required
• Determine which of the already pre-execution approved scripts are to be used for regression testing
• Review regression test cases
• Aid the testing team to log and track defects
• Interact with the development team to understand the cause of these defects and have them resolved
• Authoring Validation Plan and coming up with the overall validation strategy for the project
• Creating PowerPoint presentations to relay the validation efforts required to the higher management
• Maintaining the User stories, User Requirements and Functional Requirements in the Release Management Tracker module on ServiceNow platform
• Performing Risk Assessment to determine the testing level required for each requirement
• Actively participate in Impact Assessment meetings and Technical design meetings to better understand the system and design test scenarios
• Create PowerPoint presentations of test scenarios of high visibility requirements and relay the same to the appropriate stakeholders
• Review System Test Protocol and User Acceptance Test Protocol and the overall testing strategy
• Provide positive and negative testing scenarios for GxP related requirements
• Review Test scripts and ensure that they are compliant with Confidential & Confidential standards.
• Handle Defects on HPALM.
• Review the Traceability matrix, System Test Report and the User Acceptance Test Report.
• Participate in compliance activities including SOP (Standard Operation Procedure) creation/revision, training exercises and weekly meeting.
• Author Validation Report
• Coordinate with the documentation signatories to get training for their EDMS access
• Render documents on EDMS and route them for approvals, set expectations and follow-up with signatories for document sign-offs
• Maintain Project Plan
• Co-ordinate with supporting teams and project specific departments to ensure successful functioning of systems to develop and supervise cross-functional processes and procedures.
• Coordinate, create, populate, track and maintain databases for tracking validation activities and test results
• Create and handle Change controls for QA and PROD migrations
• Review Infrastructure IQ and OQ scripts pre-execution and aid them in documenting the same.
• Engage in technical discussions with the technical team and testing team to get a handle of the system.
• Review scripts post-execution, verify evidences and help the testing team log and track defects.
• Lead an offshore team to complete the validation efforts on time
• Proactively involve in team meetings to help the project management team define time lines for various phases of the project and set expectations for the time required for document preparations and getting them approved
• Develop PowerPoint presentations to relay validation efforts involved in the project to higher management
• Review of Validation Analysis of Service Now (IRIS) in which CMDB was encased in and determine if it required updates due to the activities of this project
• Review and aid in the preparation of Validation Plan - develop Validation strategy and determine documents needed to enable implementation of Agile methodology to a GxP system
• Proactively involve in User stories gathering sessions and discussions, maintain the User Stories on Release Management Tracker module on ServiceNow platform, derive URS and FRS from User stories and maintain them on Release Management Tracker
• Review Sprint Backlog and engage in sprint demos to get user feedback and assess their impact on documentations and their timelines
• Engage in Impact assessment meetings to determine what impact the development of new requirements have on existing features of the system
• Gain technical expertise of the system and its targeted modules by participating in meetings aimed at designing and reviewing Technical specifications and by carrying out discussions with the Architects, development team and the Global process owners
• Take the lead on creating and closing out Change controls for both QA migrations and PROD migrations
• Engage with development team to resolve any defects identified during pre-QA testing/dry runs/Ad-hoc testing
• Review and aid the creation of System Test Protocol and User Acceptance Protocol
• Assist in developing testing strategy for a variety of requirements including migration requirements
• Develop PowerPoint presentation to showcase test scenarios for GxP critical requirements with high visibility and relay the same to the appropriate stakeholder including Business owners, Global Process owners and Risk Assurance team
• Review System Test scripts and Test cases
• Aid designing of UAT Test scripts for the stakeholders and end-users and review the UAT test cases
• Interact with the HPALM team to identify the list of trainings required to be completed by end-users in order to get access to HPALM for UAT and follow-up with their trainings
• Engage with testing team to maintain defects on HPALM and carry out meetings with development team to have them resolved
• Review and aid the creation of System Test Report and UAT Test Report
• Review and maintain Traceability Matrix
• Review Sprint Retrospective and Release Retrospective
• Review and aid the creation of Validation Report
• Proactively engage with the core scrum team during the Hypercare period to help them classify critical defects and have them fixed within the stipulated timeline, communicate the non-critical defects to the steady state team and schedule these defects to be fixed in their steady state releases
• Perform remediation activities to address internal audit findings
• Review of User Requirement Specification document, Functional Requirement Specification document, Validation Plan, Master Test Plan and System Test Protocol
• Preparation of FMEA Risk assessment document - carrying out discussions with Business owner to determine the Severity and Potential effects of failure of a requirement on the system and its users, lead discussions between technical team and business owners to identify the potential causes of failure and the current process controls to mitigate the risk, determine teams that are responsible for further actions for each requirement in case of requirement failures and develop Proactive/Reactive solutions to mitigate/resolve such issues
• Review of System Test Scripts and UAT test scripts and aid designing/revising of test cases to cover negative and regression testing
• Maintenance and review of Traceability Matrix

Confidential, San Francisco, CA

Technical Writer/Validation Analyst

Responsibilities:

• Prepared documented procedures of the Validation life cycle for laboratory equipment qualification and maintenance to ensure compliance with FDA regulations.
• Validated computer systems and laboratory instruments using cGLP guidelines and 21 CFR Part 11 to maintain electronic records and signatures.
• Developed Validation Master Plan (VMP) for the implementation of CTMS and the interface with the instruments based on CSV Risk Assessment.
• Documented and reviewed Standard Operating Procedures for the various modules of the system.
• Documented test plan and designed Integration and System test cases for the standard Crystal Reports and ad-hoc reports using Query Tags.
• Reviewed validation procedures of OQs and PQs
• Performed GAP Analysis against the user requirements and provided analytical input for remediation
• Reviewed and prepared Protocols and Summary reports.
• Performed and implemented quality reviews of product documentation.
• Updated Work Instructions for utilizing the functionalities of the equipment.
• Documented subsequent updates to lot functionalities in a maintenance plan.
• Generated SQL Queries in Documentum Administrator to run the audit trail reports.

Confidential, Memphis, TN

Validation Analyst / Technical Writer

Responsibilities:

• Worked on the Validation of BarTender Label Software, Rework Database, and Certificate of Conformance Database which are Customized Off the Shelf software applications.
• Worked closely with users, and the enterprise application group to understand and document user requirements, and functional design specifications.
• Involved in validation of processes used for the development of Implantable Pulse generators, Spinal Cord stimulation and Deep Brain stimulation devices.
• Contributed towards the proposal and implementation of extensive documentation for validation life cycle which included: IQ, OQ, PQ protocols.
• Reviewed and executed the validation test scripts for various modules of the applications in the test environment.
• Developed Validation Master Plans for BarTender Label software, Rework Database and Certificate of Conformance to outline the testing activities.
• For Rework Database coordinated with the Application Development Team and training Technicians to find the system defects in the Trail testing prior to the OQ testing.
• Performed Gap analysis and developed Remediation plans for the deviations occurred during the validation processes.
• Prepared and used the Requirement Traceability Matrix (RTM) to gauge the progress on a regular basis.
• Wrote and conducted the User Acceptance Test (UAT) scripts for various real time scenarios used by the users.
• Prepared Validation Summary Reports (VSR).
• Coordinated with the quality assurance team in developing SOP’s including change control procedures and trained users on SOP’s.

Confidential, Summit, NJ

Validation Analyst / Compliance Analyst

Responsibilities:

• Identified and validated high potential business opportunities for stakeholders and developed customized business strategies that are aligned with corporate strategic objectives.
• Prepared Business Process Models and followed waterfall SDLC approach for validating the CTMS and CDS that includes modeling of all the activities of business from conceptual to procedural level.
• Worked with the project managers to gather the User Requirement Specifications and Functional requirement Specifications (URS and FRS) for the Clinical System Software (CTMS and CDS).
• Interviewing business area experts, asking detailed questions and carefully recording the requirements in a format that can be reviewed and understood by both business people and technical people.
• Conducted JAD Sessions to develop an architectural solution that the application meets the business requirements, resolve open issues, and change requests.
• Followed the UML based methods using Rational Rose and MS Visio to create Use Cases, Activity Diagrams, Sequence Diagrams, Collaboration Diagrams
• Conducted document analysis on existing system documents (detail design and system manuals) and Statement of Procedure (SOPs) to capture the decisions being made by system.
• Conducted analysis on existing business process models and value stream maps to identify crucial process steps to be changed.
• Worked with existing different operational and client team to capture reporting requirements, define threshold and event based reporting requirements
• Conduct GAP Analysis and prepared Remediation Plans.
• Accomplished regression, positive & negative testing for laboratory equipments and prepared Test cases & Test scripts.
• Authored and executed Test Scripts for performing the Operational Qualification Performance Qualification (OQ and PQ) of the CTMS and CDS.
• Involved in the User Acceptance Testing to validate the Clinical Data Management Software.
• Conducted Load, Stress & Performance testing using Load Runner.
• Performed Manual and Automated Testing Using Quick Test Professional.
• Performed Bug tracking and Reporting using Mercury Quality Center.
• Maintained Requirements Traceability Matrix (RTM) and documented the summary report.
• Developed, organized and managed multiple tasks with effective time management.

Confidential, Latham, NJ

Quality Analyst / Technical Writer

Responsibilities:

• Wrote and analyzed the system specification covering User Requirements and Functional Requirements
• Validated Laboratory Information Management System (LIMS), Applied Biosystems SQL*LIMS
• Validated Computer Systems for compliance with 21 CFR Part 11 and cGXP regulatory standards
• Created Test Plans, Test cases & Test scripts, executed these test cases and documented test results for Argus AERS system in compliance with FDA regulations
• Authored training materials and conducted training sessions for system testers and end users
• Developed and maintained Validation Master Plan
• Prepared Standard Operating Procedures (SOPs), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for laboratory equipments like Spectrophotometer, Chromatography (GC & HPLC), Incubator, Autoclaves and other analytical instruments
• Preparing Quality Review Reports and validated existing SOP’s and Batch Reports
• Quoted Remediation Plans for the gaps found and maintained Requirements Traceability Matrix (RTM)
• Conducted Load, Stress & Performance testing using Load Runner
• Performed Manual and Automated Testing Using Mercury Test Suite (QTP)
• Performed Bug tracking and Reporting using Mercury Quality Center