SUMMARY

• 8 plus years of experience as a Validation Analyst in Pharmaceutical & Life Sciences industry.
• Through knowledge of 21 CFR Part 11, 50, 210, 211, 820 and experience working in cGMP, cGLP, and cGCP suites.
• Well versed with technical writing of Validation documents like Validation Master Plan (VMP), Validation Project Plans (VPP), Installation Qualification, Operational Qualification, Performance Qualification, Data Migration protocols, RTMs, IOQRs, and Summary Reports.
• Understanding of GxP Environments, GAMP guidelines and FDA Regulations.
• Specialized in gathering User requirements, Business Requirements and System Requirements and deciding the scope and strategy for Projects.
• Involved in 21CFR Part 11 and audit trail validation process.
• Well versed with GAP Analysis, Remediation Plans, Trace Matrices and Risk Assessments.
• Authored Deviation Reports and prepared Final Validation Report.
• Reviewed completed projects for accurate implementation based on project requests received.
• Good knowledge of LIMS Lab ware, Empower, Database systems and PeopleSoft.
• Expertise in using automated testing tools like QTP and HP Quality Center (QC).
• Experience in Requirements gathering and performing Functionality Testing, GUI Testing and Regression Testing.
• Proficient in dealing with Standard Operating Procedures (SOPs), Test Plan, Laboratory information management system (LIMS), Adverse event reporting system (Argus safety AERS).
• Extensive knowledge of Lab Chromatography Equipments (HPLC, GPC, GC, coupled with MS).
• Infrared UV detector (FTIR/ FTNIR.).
• Through knowledge of 21 CFR Part 11, 50, 210, 211, 820 and experience working in cGMP, cGLP, and cGCP suites.
• Experience in performing GAP analysis, Remediation Plans and preparing SOPs.

TECHNICAL SKILLS

• 21 CFR Part 11
• Validation protocols
• LIMS
• Gap Analysis
• RTM
• Audit Trials
• Remediation
• Temperature Mapping
• Qualification
• Project Closure Reports
• Analytical Equipment (HPLC qPCR
• Thermocyclers
• Heat Blocks
• Threshold Chemistry Analyzer
• GC
• Spectrophotometer
• Plate Readers
• Incubator Shakers
• Incubators
• PCR
• HIAC 9703+ Particle Counter
• Accusizer Particle Counter
• URS
• SOPs
• Validation Project Plan (VPP)
• URS Assessment
• GAP Assessment document
• Vendor Protocol Assessment
• Gap IOQ
• Generic Test Protocols (GTP)
• Requirement Traceability Matrix
• Release Reports
• Protocols Summary Reports (IOQRs)
• Generic Test Report (GTR)
• Validation Summary Report (VSR)
• GAMP Categorization
• Log - books.
• MS Office (Word
• Excel
• PowerPoint
• Access)
• Valgenesis
• MasterControl
• CMMS
• Electronic Documentation Control (EDC)
• UML
• Outlook
• Trackwise
• Saba
• Kaye Validator
• Ellab
• MS Lync

PROFESSIONAL EXPERIENCE

Confidential, Lexington, MA

AIQ Engineer- Quality

Responsibilities:

• Developed Validation Documents such as Impact Assessment/Risk Assessment, Validation Plan, User Requirements Specification, Design Specifications, Design Review, Factory Acceptance Test, Installation/Operational Qualification, Requirements Traceability Matrixes, and Validation Summary Reports for various types of clinical manufacturing equipment types.
• Extensively utilized the Kaye Validator 2000 and Ellab System for thermal mapping of ovens.
• Created and Executed Site Acceptance Test (SAT) Protocol and Drafted Final summary report.
• Reviewed and approved Validation Protocols (IQ, OQ and PQ) for Centrifuges, Refrigerators, Freezers, and Incubators.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Involved in Validation Process and documentation of Validation Project Plan.
• Involved in gathering the User Requirements from the System Owners document for all the software components.
• Developed FRS (Functional Requirements Specification) and DS (Design Specification) from the URS (User Requirement Specification)
• Validated Analytical lab equipment like Mettler Toledo Titrators and Balances, Perkin Elmer Micro beta Scintillation Counter, qPCR, Spectrophotometers, Thermocyclers, Endotoxin Testing system, and some other Lab equipment’s.
• Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Developed Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Responsible for writing change control SOP’s to comply with 21 CFR Part 11requirements.
• Worked on GAMP4/GAMP5 based validation.
• Wrote SOPs for each instrument at different levels in accordance with GAMP regulations.
• Verified that data for all the systems are backed up daily on the servers.
• Worked with IT to ensure compliance with Part 11 backup and restore requirements. Responsible for writing and revising Standard Operating Procedures for the Utility Systems and Validation Procedures.
• Responsible for the preparation, review and execution of Installation and Operational Qualification (IOQ) protocols for the HVAC System.
• Executed Factory Acceptance Tests, Installation/Operational Qualifications, and Performance Qualifications for control systems used to monitor and control the operation of CIP skids.
• Generated Change Controls with collaboration of the systems’ owners to keep compliant with the growing demand for innovation and changing project needs.
• Responsible for the Process Validation of multiple products and process equipment that had direct impact on product. This included equipment that made contact with product. (High risk Direct Impact).

Confidential, Chicago, IL

Validation Engineer

Responsibilities:

• Validated a range of lab equipment. Generated, executed and summarized IQs OQs and PQs.
• Authored risk assessment reports.
• TD Studies: incubators, freezers, refrigerators and walk in cold rooms.
• Cleaning studies: Production scale HPLC and Ion Exchange columns and HPLC skid.
• Reviewed data and summary reports forautoclavesand fermenters requalifications.
• Wrote the IQ/ OQ and PQ protocol for the vial washers, liquid filler & stopper, capper, depyrogenation tunnel and Automatic Loading & unloading systems forLyophilizer.
• Developed process specification for a newLyophilizer.
• Pre-reviewed and post reviewedvalidationprotocols for a revamp liquid filling line and buildingequipment. i.e. Filler, Tunnel, Washer, WFI, Clean Steam, Thaw bath and HVAC for clean rooms
• Provided oversight for the site cleaning validation program and cleaning of manufacturing equipment to prevent cross-contamination between Active Pharmaceutical Ingredients (API).
• Designed, developed, delivered, and maintained site-wide cleaning validation program for manufacturing equipment, ensuring adherence to standard operating procedures (SOPs).
• Investigated with QA, developing response strategies forAutoclave, CTU, CIP and SIP compliance issues.
• Coordinated with QC and system user. Scope included conductivity/TOC rinse samples and TOC swabs. Coordinated and executed up to sixvalidationssimultaneously.
• Responsible for the generation of testing protocols covering all aspects of manufacturing and cleaning processes for the product including blending, granulation, tableting, encapsulation, coating operations, bottling, blister packaging, pouch fills and all equipment cleaning.
• Mapped and validated campus environmental chambers (refrigerators, incubators, and ovens) via GE Kaye Validator 2000 and wireless Val-Probe systems.
• Performed qualification, troubleshooting, and repair of HPLC, IC, UV-Vis, FTIR, and DissolutionInstrumentation.

Confidential, Indianapolis, IN

Validation Analyst

Responsibilities:

• Developed and executed Validation Test Plans, IQ/OQ protocols and modifying and generating supporting SOPs and Quality Project Plans and assisting with computer validation projects to ensure the development, execution, and completion of computer validation efforts are in accordance with company policies, standards and regulatory expectations.
• Validated the implementation of PeopleSoft in Commitment Control, Accounts Receivables, Billing, Purchasing, Accounts Payables, Travel and Expense, Grants and General Ledger.
• Involved in analysis and design of Test plans, Test Cases and Test procedures
• Assured that all validation documentation such as IQ, OQ Process Validation, and Software Validation are in compliance with cGMPs.
• Conducting walkthrough of the Validation Plan with the development and design teams.
• Documented all aspects of computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21 Part 11.
• Involved in IQ, performed OQ by running Test Cases and Test Scripts.
• Performed Installation and Operational Qualification (IQ/OQ) for facilities, equipment and systems
• Ensured that the entire process complied with the FDA 21 CFR Part 11 standard
• Identified software defects, reported and tracked using internal defect management process.

Validation Engineer

Responsibilities:

• Was involved in gathering User Requirements, conducting Gap Analysis and preparing the Remediation plan.
• Involved in requirements gathering and analysis and developed Test Plans and created Test Cases
• Involved in different phases of Project Life Cycle.
• Involved in Data Migration and Back-end Validation testing.
• Involved in the CSV and Equipment qualification for the Waters Empower 1 and Empower 2 systems.
• The activities included the validation of the software used by the analytical laboratory instrument (chromatography instruments, infrared UV detectors) and production equipment (HMI & PLC, and Molding machines for contact lenses manufacturing).
• Wrote all the CSV deliverables (from VP, URS… to VSR) in accordance with GAMP 4 guidelines.
• Provided administrative support for Laboratory applications such as Chromatography Data Systems and LIMS within the QC and Bioscience organization.
• Managed routine functions such User List maintenance and Permission grants.
• Gathered, understood and documented business objectives, specifications, and requirements on assigned projects.
• Provided cross-functional and business knowledge to develop business system and process alternatives.
• Provided strong knowledge of an enterprise and cornerstone system such as SQL*LIMS and Waters Empower.
• Responsible for quality review of the Installation, Operational, and Performance Qualification documentation of start-up drug manufacturing processes and equipment, including protocols, final reports, etc.
• Validated pharmaceutical computer systems, manufacturing facilities and process equipment at client site following GAMP, FDA, GxP, and 21 CFR Part 11 regulations.
• Developed and executed system test cases, scripts and plans based upon business flows and processes.
• Maintained Requirements Traceability Matrix (RTM) to track requirements.
• Involved in the validation lifecycle for (IQ/OQ/PQ) as a validation engineer, assist in testing the application to ensure that it meets all functional requirements.
• Implemented and executed IQ, OQ, and PQ validations for a new production facility.
• Reported progress of protocol and validation work and significance of results.
• Recommended utilization of the results or changes in the scope of work or termination of projects.
• Reviewed the UAT test scripts against URS to ensure the proper test coverage.
• Performed GAP analysis to ensure adherence to all user requirements and devised Remediation Plans.
• Reviewed the Final Test Summary Report before submitting to internal and external auditors