SUMMARY

• 6 years of experiences in Pharmaceutical and Medical Device Industry with expertise in Quality Assurance, Computer System Validation and Technical Documentation in FDA regulated environment.
• Good understanding of Programmable Logic Controllers (PLCs), DeltaV Distributed Control Systems (DCS) and SCADA.
• Quality SME for Data Integrity and maintain contemporary knowledge of regulatory requirements, and industry trends, and enforcement actions.
• Experience managing Corrective and Preventive Action (CAPA), Nonconformance (NC) and Change Control records as lead Quality contact.
• Experience in Developing, Reviewing, and approving Test Plans, Test Scripts, Test Procedures, and Test Summary Reports of all the laboratory equipment’s.
• Performed and Assisted Validation team in creation of Data integrity assessment as per ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) Standards.
• Expertise using TrackWise QMS for Tracking and monitoring Change Control implementations.
• Strong knowledge in GxP regulations and GAMP principles, Annex 11 and guidelines with an emphasis in 21 CFR Part 11, 210, 211, 58, 312, 812 and 820 Compliance.
• Good understanding on Production and Inventory Operations Management, Quality Operations Management, Performance Management, Enterprise Integration.
• Author, execute, perform, and summarize CSV documents: Validation Plans, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, and Deviation Handling.
• Expertise in maintaining and assuring completion of computerized system change control request documentation.
• In - depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
• Held overall responsibility of ensuring effective CSV deliverables for TrackWise and TrackWise Analytics implementation.
• Expertise in drafting the Corrective and Preventive Action Plan (CAPA) and performed the GAP analysis to remediate audit findings and observations given by the auditors for regulated Research and Development (R&D) applications.
• Well versed in software development life cycle (SDLC) process, which is used for planning, creating, testing, and deploying computer information system by using Waterfall Model and Agile technologies.
• Extensive experience in Performing Functional, System, UAT, Regression testing using both HP Quality Center/ HP ALM.
• Expertise in performing Black box Testing, Regression Testing, and Integration Testing Front End Testing, Functional Testing, and also automated testing tools like HP Quality Center.
• Extensive knowledge in writing templates for URS and FRS.
• Skilled in developing a gap analysis matrix and conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV.
• Experience using Kneat e-Validation software for digitized qualifications of all SDLC documents.
• Extensive experience with Test Execution Reports, Incident Reports, DCIMs, DSATs and ACPs.
• Experience using PIMS HQ to create, manage, communicate, and deliver projects through a single interface while monitoring and tracking the progress and reporting in real-time visibility.
• Tracked all deviations and corrective actions as part of test process.
• Experience in MES systems and Building Management Systems.

PROFESSIONAL EXPERIENCE

Confidential, PA

Quality Assurance Specialist

Responsibilities:

• Currently working as a Quality Assurance Specialist in Data Integrity, Remediation and Modernization Projects.
• Responsible for Reviewing and approving Requirement Specifications, Configuration Specifications, Requirements Traceability Matrix (RTM) for Lab instruments.
• Responsible for Reviewing and approving Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ, and Performance Qualification - PQ) and UAT protocols for Lab instruments.
• Worked with Validation Engineers to develop and maintain Quality Assurance Plan (QAP).
• Reviewed and approved Data Migration Plans, Quality Assurance Summary Reports and Risk Assessment Plans.
• Reviewed and approved new and revised SOPs related to Laboratory Equipment operations and Administrations.
• Developed a Document tracker for SOPs migrated from MIDAS (Members Information Documentation Authorization System) to VeevaVault / QualityDocs (QMS).
• Worked with teams in migrating from MIDAS CDS and R&D to MEDS (MIDAS Modernization) for Document Tracking, Version Controls and workflow management throughout document life cycle.
• Involved in system enhancement process within various business workflows like CAPA, Change Control, Audit and Deviations
• Reviewed change control documentation and performed testing assessments based on Risk Assessment.
• Ensured System Requirements were analyzed and documented in Function Requirements Specification (FRS) and Design Specifications (DS).
• Performed audits of qualification, validation, GMP and quality systems. Provided summaries of status and remediation plan.
• Responsible for Integration of Data Integrity requirements and best practices into the computerized system validation lifecycles for quality control instruments, data analysis systems, and local instances of enterprise systems.
• Ensured that the root cause of deviation was investigated and helped develop resolutions for the deviations to be documented in TER (Test Execution Report).
• Reviewed and approved Criticality Risk Assessment (CRA) for new systems and modified systems.
• Used TrackWise for tracking and monitoring Change Control Implementations and create Change Requests.
• Reviewed and approved Clarification documents for additional testing justification of systems that needed Re-qualification.
• Implemented cGXP's (GMP, GLP, and GCP) and GAMP 5 guidelines in the systems.
• Ensured that documents were updated for systems that were upgraded from NuGenesis and configured to Acronis for Data Archival and backup.
• Used PIMS HQ to create, manage, communicate, and deliver projects through a single interface while monitoring and tracking the progress and reporting in real-time visibility.
• Trained Quality Team on Review and Approval process of Test Execution Reports, Area and Incident DCIMs, DSATs and ACPs using PIMS HQ and Kneat e-Val for Delta-V Remediation.
• Reviewed medical device labeling and advertising materials for accuracy and completeness.
• Conducted daily Check-in meetings and interacted with Business Owners, System Owners, Business Analyst, Validation Analysts and Technical Unit to maintain the timelines for the Project and maintained the tracker for the Project to track deliverables.

Confidential

Sr. IT QA Engineer

Responsibilities:

• Represented Quality Team in Validating Automation activities for SCADA, BMS and DeltaV systems.
• Prepared FDA CFR Part 11 Gap assessments to develop remediation plans to improve the business process and the efficiency of GxP system.
• Reviewed and Assisted Validation Team in Creation of Data Integrity Assessments as per ALCOA Data Integrity Principles.
• Reviewed IQ/OQ for Process Control Systems (PCS) for Control Panel Drawings Remote I/O, Loop Checks,
• Reviewed and approved quality assurance plans, User requirements and Design Requirements, test plans.
• Led Automation Change Control Management Program and approved Change Controls.
• Approved Functional Requirement Specification (FRS), System Test Scripts, UAT scripts, Test Plan, Test Report.
• Reviewed and approved Validation Master Plan, validation documentation, including Risk Assessment, GAP Analysis, Remediation Plan, Validation Plans, IQ, OQ and Validation Reports.
• Reviewed and approved in Batch systems, Validation Documentation.
• Reviewed and approved qualification and process validation of a sterile vial filling machine, stopper and washer vials of varying configurations.
• Reviewed and approved documentation for packaging equipment, inspection systems & aseptic processing equipment to ensure compliance with CFR Part 11.
• Performed cGMP compliance audit and self-inspection to evaluate the overall cGMP compliance of the solid dosage manufacturing facility.
• Reviewed and approved system testing for Service Now, Sales force to ensure the functionality of the system.
• Reviewed and approved Validation Summary Report (VSR), Change Summary Memo (CSM), and Test Summary Memo (TSM) for Complaint Manufacturing Process Validation (cGMP).
• Prepared protocols for Test Deviation document for the failed test executions.
• Reviewed the product andbusiness requirementsand updated companies existing SOP’s.
• Approved validation protocols for validating Service Now, Sales force, datasheets, and reports.
• Involved in prioritizing, analyzing, and resolving technical issues during system Upgrade of Service Now.
• Coordinated with departments for full execution of test scripts for Service Now, Sales force systems and activities like preparing agendas for the project, production of documents, scheduling meetings and maintaining files.
• Supported Quality Management efforts, assemble documentation for audits and ensure documentation is complaint with the federal regulations and applicable standards.
• Reported problems in test execution in order to determine if any actions are required such as upgrading and replacement.

Confidential, IL

IT Quality Assurance Engineer

Responsibilities:

• Interpreted, understand, and assist in the development of technical documents such as P&ID, Instruments Lists, Logic Diagrams, Loop Diagrams, and Elementary Diagrams.
• Reviewed and Approved DeltaV IQ/OQ protocol to include Phases, Equipment Modules (EM), Alarms (Functional and Configurational), Recipes, Interlocks.
• Supported activities in defining automation project objectives, plan automation project budgets, schedules, and priorities.
• Participated in Design automation and process control systems for both DCS and PLC environments.
• Supported team of automation and instrumentation engineers for larger projects.
• Provided technical analysis, develop alternative solutions, prepare cost estimates, determine feasibility, prepare design documents, etc.
• Supported Design control system hardware/software architectures, based on standard products, including electrical/mechanical design of process control panels.
• Reviewed vendor submittals for valid technical design.
• Wrote detailed and concise technical documents.
• Created Data Integrity Self-Assessment on TrackWise and drafted Remediation Plans.
• Conducted Risk Analysis meetings to analyze the risk involved in implementing the TrackWise system in the existing business process.
• Involved in Design and deployment of SAP systems to replace paper based or manual systems including batch records, warehouse management and material tracking in a pharmaceutical environment. Developed SDLC and validate ERP, Wizards, MES system integration with the SAP system and/or control equipment (HMI, PLC, and Network).
• Held overall responsibility of ensuring effective CSV deliverables for TrackWise implementation.

Confidential, IN

Computer Systems Validation Engineer

Responsibilities:

• Responsible for performing end to end validation for Lab instruments.
• Validated End to End Automation Process Control System (PCS) using DeltaV and BMS.
• Initiated Lab Automation Change request for Validation /Verification of Core/Site LIMS and created Template objects as per Business Requirements.
• Developed User Acceptance Test Scripts, other SDLC documents for Integration Testing / Workflow verification and system functionality testing.
• Conducted Dry runs to finalize the User acceptance testing Scripts for all the equipment’s and verified all the Data Integrity requirements and Audit trials.
• Developed Validation Summary report to summarize all the validation deliverables.
• Performed Gap analysisand prepared Remediation Planaccordingly to maintain compliance according to regulations.
• Provided support in the preparation of IQs/OQs/PQs and Decommissioning protocols for manufacturing equipment such as tanks, pumps, autoclaves, freezers, refrigerators, incubators.
• Maintain and administer the change control program for qualification of the equipment and facility.
• Developed and Executed the OQ’s to verify the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Authored and maintained the Requirements Traceability Matrix (RTM), Test Report, Validation Registry as per the SOP’s.
• Setting up test environment for each business area and demonstrate traceability to requirements and developed Requirements Traceability Matrix (RTM).
• Coordinated and managed the validation and qualification strategy for the lab equipment.
• Develop and maintain validation and qualification system level documents including master validation plans.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Conducted Regression Testing for the affected functionality by proposed changes to the production system.
• Actively Participated in the process of decommissioning and records retention process, in order to achieve local IT operations shutdown.