Extensive experience and Consistent top performer as a Validation Engineer in the pharmaceutical, CRO, Drug Development and Medical device industries across all verticals with international exposure.
Good Knowledge of current industry standards, such as 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 312, 21 CFR Part 820, ISO, SOX and Capability Maturity Model (CMM).
Experienced in the generation and execution of Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM) in validation deliverables.
Good understanding of Testing Life Cycle (TLC) and Software Development Life Cycle (SDLC)
Experience in preparing Standard Operating Procedures (SOPs), GAP analysis and preparing remediation plans with the knowledge of project management.
Familiar with FDA Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs) regulations, Part 11 Electronic Records, Electronic Signatures requirements, ICH guidelines.
Extensive experience with TrackWise, Laboratory Information Management System (LIMS) and Adverse Event Reporting System (AERS).
Experience with Corrective action and Preventive action (CAPA) and Change Control Validation.
Experience working with electronic Document Management System (DMS) like Documentum, SharePoint to archive and retrieve documents.
Well versed with FDA regulated environment.
Good analytical skill and have expertise working with GC/MS, HPLC
Excellent in verbal and communication Skills with strong analytical and problem solving ability.
Proven ability to work efficiently in both individual and team based environments.
Computer System Validation
21CFR (11,210,211 and 820), GAMP, cGxP, RTM, UR, SOP’s, Validation Protocol (IQ, OQ, PQ), GAP Analysis, Water Empower, Documentum (6.0 and 6.5).
LIMS, Documentum, TrackWise, AERS, HL7
Windows OS, MAC, UNIX
Oracle, MS SQL Server, Informix
Waterfall and V Model
QTP, Load Runner and Quality Center
2003-2010 (Word, Excel, Access, Front Page, Power Point, Photo editor).
Adobe Acrobat 7-10, Adobe Photoshop
Covance Central Laboratory Services, IN Mar 2014- Present
Quality/Validation Lead-Global Information Systems
Covance is one of the world’s largest and most comprehensive drug developments services company. Covance has helped Pharmaceutical and Biotech companies develop one-third of all prescription medicines in the market today. I was responsible for validating the Migration of Project Management and Operations, which is a project of validating migration of the entire active and historical client projects from legacy Clinical Data Management System to Labware LIMS V6.
Created the enhancement assessment matrix for the upgrade and categorized enhancements as impact and no impact items and risk involved with implementing them.
Created the user requirement specification for the upgrade.
Lead and review the creation of IQ, OQ, PQ protocols.
Lead and review IQ, OQ, PQ scripts and assign and review the Dry Runs.
Lead and review OQ scripts which involved configuration and migration from one environment to other using Configuration Migration Utility.
Participation in creating risk assessment document.
Created validation plan, test plan, technical architecture specification documents as per FDA and company standard.
Involved in creation of new templates and forms to bring consistency in documentation for other projects too.
Utilized HPLC to determine assay concentration and cross contamination on all samples
Worked with GC and ICP to determine assay concentration for specific samples
Tested and analyzed the design to optimize the function, appearance, and manufacturing of
new parts and assemblies.
Designed the training plan for the end users and local administrators for TrackWise.
Lead and manage the testing task onshore and offshore.
Responsible for managing the discrepancies and maintaining the discrepancy log file.
Used compliance wire to issue the training to the end user and local administrator.
Involved in revising the SOPs for different sites.
Involved in resolving issues with Sparta System faced during the upgrade.
Involved in project scheduling and deciding timelines for activities related to validation.
Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases using QC.
Responsible to define test requirements, run manual and automated tests, add and track defects using Mercury Quality Center.
Responsible for creating and executing test scripts in accordance with good testing practices and good documentation practices.
Designed validation of instrument systems and ensured compliance with quality system requirements.
Prepared protocols for following cGLP and cGMP procedures.
Attended daily status meetings with Project Management on testing updates.
Involved in preparation of Validation Summary Report (VSR).
Baxter Healthcare, Deerfield, IL Jun 2012 – Feb 2014
Baxter is a global leader in delivering critical therapies for life-threatening conditions. All Baxter technologies are related to the blood and circulatory system. As a validation Consultant, I was Responsible for validating the Lab Releases, which is a project of migration of all lab instrumentation to interface LIMS V6 from Siemens CentraLink interface.
Validated the system in compliance with Software Requirements and Regulatory Requirements.
Created the test plan for protocol execution and conducted tester training for the test script execution.
Involved in Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, and Performance Qualification (PQ) Specification.
Reviewed the business requirements and the existing test cases and product requirements.
Actively participated in developing validation procedures and test scripts.
Performed functional testing and integration testing on the new releases of the system.
Used TrackWise for bug tracking and reporting.
Assisted in preparing the Validation Test Summary Report.
Maintained the requirements for Traceability Matrix (RTM).
Drafted new SOP’s and trained all users on the systems.
Managed the validation projects for various systems and sub-systems.
Involved in preparation of Validation Strategy Document.
Checked for conformance and standards before and after validation of the spreadsheets.
Involved in GxP assessments of spreadsheets.
Involved in variance resolution reports and prepared the required documents for the same.
Participated as a team member in writing project plan to provide project objectives and approach to the management for the formal approval.
Genentech, San Francisco, CA Jan 2011-May2012
Genentech is among the leading biotechnological companies, which produce products to treat patients with life threatening conditions. Change Control Management (CCMS) is an in house application that provides a proactive, automated and integrated approach to infrastructure; I worked as a validation analyst in validating their Global Complaint System and its Releases.
Involved in gathering user requirements and functional requirements.
Involved in writing validation plans.
Conducted meetings with the system users to gather user requirements.
Participated in updating the Requirement Traceability Matrix.
Developed and executed the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts for the new functionalities.
Involved in documenting and executing validation plan, test cases and test scripts.
Participated as a team member to draft a remediation plan for project management approval after Gap Analysis.
Prepared validation summary reports and standard operating procedures (SOPs).
Provided input and feedback to the QA team in the execution of the test plans and test cases.
Reviewed change control documentation for instrument and equipment related work instructions for quality and compliance issues.
Trained users on the system operation and data entry into ELN.
Responsible for supervising junior testers and participating in performance reviews periodically.
Teva Pharmaceuticals, West Chester, PA Oct 2009 – Dec 2010
Teva pharmaceutical industries is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals as well as active pharmaceutical ingredients.. I was involved in customization and validation of Lab Ware LIMS as per predicate rules. Guidelines were prepared for the integration and validation of new laboratory instrumentation in compliance with cGxPs and quality requirements.
Participated in Validation Life Cycle (VLC) planning, implementation and documentation.
Created a GMP assessment and 21 CFR 11 assessments to determine if any or all functions are under relevant FDA regulations.
Managed system upgrades, enhancements, and maintenance in a cGMP environment.
Carried out risk assessment to analyze and quantify different risk areas in the system.
Validated the process to comply with the FDA rules and regulations.
Helped conducting vendor assessments - reviewed quality policies and testing practices.
Developed Validation Master Plan (VMP) approved by the IT quality manager.
Reviewed User Requirement Specifications (URS) and System Requirement Specifications (SRS) document to ensure completeness and correctness of validation.
Created Requirement Traceability Matrices (RTM).
Developed Standard Operating Procedures (SOPs).
Involved throughout the testing and documentation phase of the system validation project.
Authored validation protocols Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) test plans and test scripts.
Designing Extraction Transformation and Load (ETL) process work flows.
Executed test scripts developed by other team members.
Wrote Test Summary Report (TSR).
Performed GAP analysis to check GAPs in the risk assessment.
Participated in User Acceptance Testing (UAT) to make sure that all the user requirements are met and maintained communication with team members.
Helped in developing Validation Summary Report (VSR).
Sun Pharma, India. Jun 2008- Sep 2009
Validation Engineer / Quality Assurance
Sun is one of the leading medical technology companies in India and is dedicated to help healthcare professionals perform their jobs more efficiently while enhancing patient care. I worked on quality systems to maintain, document and improve quality compliance and standards of products throughout the manufacturing line in adherence to FDA regulations.
Worked on CAPA systems, internal and external quality audits, and management reviews.
Worked on FMEA's, customer complaints and Root Cause Investigations (CAPA), Quality Management Support (QMS) activities, control plans, qualifications, process validations, gage R R's along with design verifications and design reviews, and implementation of new manufacturing processes for new products.
Gather and report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
Verify root cause and corrective action for all applicable customer complaints.
Validation Cycle included the following deliverables: URS, FS, FMEA, software Input Outputs, Controlled Source Code, Traceability Matrix, IQ, OQ, FAT, SAT, Software Validation, PQ and Master Validation Plan.
Audited manufacturing areas for documentation accuracy, process improvements and quality enhancements.
Involved in implementation of Quality System Regulation requirements at contract drug manufacturer that resulted in FDA approval.
JNT University, India
Bachelors of Engineering, Biotechnology