SUMMARY:

• Extensive validation experience in the pharmaceutical and medical device industry
• Experience as a Validation Lead for testing /validation efforts for small sized projects
• Thorough understanding and knowledge of Validation life cycle and Software Development Life Cycle (SDLC) with emphasis on manual and automated testing
• Specialized focus on qualification and validation of computer systems and analytical instrumentation
• Experience with change control management of validated systems in the Pharmaceutical industry
• Involved in product development from requirements analysis to design implementation and validation
• Experience working with cross functional project teams to coordinate the validation activities and determine the project timelines
• Knowledge and competent in Quality system and standards (GxP), 21 CFR Part (11,210,211,820), Gap Analysis and Remediation Plans
• Hands on experience in all the activities of validation from validation planning to validation summary report
• Experience in preparing documents such as SOPs (Standard Operating Procedures), validation master plan (VMP), Requirement specifications (URS, FRS and DS), validation protocols (IQs, OQs, and PQs), Requirement Traceability Matrix (RTM) and summary reports for various computer systems
• Involve in the identification of risks and the development of mitigation strategies for projects
• Lead testing efforts on small scale projects and estimated schedules, resources and dependencies to drive the Validation efforts
• Expertise in using testing tools such as ALM/HP Quality Center and QTP
• Extensive knowledge in the Process Manufacturing, Plan To Make and Order To Cash workflows in ERP system
• Excellent Knowledge with the Pharmaceutical Biologics manufacturing process
• Proven ability to work efficiently in both individual and team based environments
• Excellent communication and organizing skills with the ability to grasp and learn new processes quickly

TECHNICAL SKILLS:

Computer System Validation: 21 CFR part11, GxP, SDLC, Validation Master Plans, URS, FRS, Validation protocols (IQ, OQ, PQ), QTP, SOP s, RTM, summary reports, executing test scripts for validation, Change Controls, Infrastructure Qualification

Computer Applications: Oracle EBS v12.1, Documentum, SharePoint, Oracle Fusion Middleware, TrackWise, HP Quality Center, Oracle Access Manager, Crystal Reports

Tools: MS - Office Suite (Word, Excel, Access, Visio), MS-SharePoint, SnagIt

Testing Tools: HP Quality Center/ALM

PROFESSIONAL EXPERIENCE:

Validation Engineer

Confidential, Foster City, CA

Responsibilities:

• Validation support of all ERP system enhancements and supporting the regular maintenance and operations of the system using Gilead’s Change Management process.
• Follow Gilead policies in all aspects of Validation activities with emphasis on Quality, GxP standards and FDA guidelines such as 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211.
• Create/ review Change requests to facilitate bug fixes/ enhancement changes/ break fix changes related to the computer system.
• Create, update and execute validation deliverables/ protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Coordinate testing strategy and testing plans in accordance with the Validation plan and as per Gilead Validation processes.
• Update and review User Requirements Specifications (URS), Functional Requirement Specification (FRS), Requirements Traceability Matrix (RTM) and Configuration and Design documents.
• Verification of the system against Design/Functional Specifications, ensure compliance of systems supporting medical/drug safety systems and tools with FDA rules and regulations.
• Impact assessment of changes on documentation, validation and testing perspective during Change review meetings.
• Manage change controls requests/ records using Trackwise system from planning stage to implementation stage.
• Create, update, review documents which has any impact to the Validation environment in Documentum.
• Collaborate with Project Managers, Technical team and Database Administrators to help facilitate bug fixes or change requests and thereby strategize Validation testing scenarios.

Validation Analyst

Confidential, Foster City, CA

Responsibilities:

• Create, update and execute validation deliverables/ protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Follow Gilead policies in all aspects of Validation activities with emphasis on Quality, GxP standards and FDA guidelines such as 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211.
• Create/ review Change requests to facilitate bug fixes/ enhancement changes/ break fix changes related to the computer system.
• Coordinate testing strategy and testing plans in accordance with the Validation plan and as per Gilead Validation processes.
• Verification of the system against Design/Functional Specifications, ensure compliance of systems supporting medical/drug safety systems and tools with FDA rules and regulations.
• Impact assessment of changes on documentation, validation and testing perspective during Change review meetings.
• Collaborate with Project Managers, Technical team and Database Administrators to help facilitate bug fixes or change requests and thereby strategize Validation testing scenarios.

Trackwise Consultant/ Software Validation Analyst

Confidential, South San Francisco, CA

Responsibilities:

• Responsible for performing validation activities in the Maintenance and Enhancement (M&E) for changes in a Global TrackWise Project, working with resources at Poland, Basel and Nutley (NJ).
• Assessment and creation of risk documentation like FRA, RCS and PHA based on the requirements.
• Design and update Requirement Traceability Matrices for various TrackWise Applications
• Analyze business requirements and designing and developing Crystal Reports for TrackWise in Oracle 10g and 11i environments
• Involved in creating and modifying IQ, OQ and PQ protocols.
• Perform dry run of the test scripts and execution in the validation environment.
• Create and design ad-hoc queries to search the Trackwise database with the reporting functionality of Trackwise.
• Gather requirements from the URS and upload into HP Quality Center (HP QC) and correspondingly create and execute test scripts using HP QC.
• Create defects or deviations encountered in test executions by following the proper defect/ deviation management procedures.
• Collaborate with the Change Control Team and QA/QC team to ensure that the changes have no potential impact to the product quality and put forward testing strategies to test those changes in GMP standards.
• Create Validation Assessments for changes that affect various TrackWise Applications.
• Identified loopholes in legacy installation procedures and documents and involved in fixing it with the developers and QAs.
• Responsible for maintaining updated and approved documentations pre and post validation activities according to GDP standards.
• Create and update validation reports and validation registry prior to release of an application.
• Involve in proper routing of validation documents for approvals before any deployments.
• Review and Approve validation documents in Project Library through E-signatures according to Part 11 standards.

Software Quality Engineer/ Validation Analyst

Confidential, Palm Beach Gardens, FL

Responsibilities:

• Develop software validation plans to determine the planned validation activities, deliverables, responsibilities and approval authorities for all computer system validation activities throughout the life cycle of the system.
• Determine user requirements to describe the required functions and capabilities derived from the users’ and overall business needs.
• Develop functional specifications to specify how user requirements are to be accomplished by defining the detailed functionality of system modules and sub-processes that carry out the previously documented requirements.
• Collaborate with senior technicians in the Production floor and Labs to transfer knowledge of the active products and processes.
• Participate in risk analysis using FMEA tools to determine what risks may impact the correct or reliable functioning of the computer-related system. This document is an FMEA (Failure Modes Effect Analysis). Develop and implement risk mitigation measures as required.
• Organize and lead meetings with team members to update and plan validation activities.
• Document and execute software installation qualification (IQ) to establish documented evidence that a system has been installed and configured per the approved design specification document(s).
• Document and execute software operation qualification (OQ) to provide documented evidence that the software and associated computer-related systems conform to user needs for their intended functions.
• Document and execute software performance qualification (PQ) to establish that the new or modified computer-related system processes, as defined in the user requirements, are effective and reproducible in a normal business environment.
• Create Validation Summary Report to summarize the qualification procedures and ensure that the software produces the expected and reproducible results.
• Support the qualification of new software suppliers to include the performance of software supplier audits.
• Consult with software users, vendors and information technology personnel to resolve hardware, software, networking, and other computer related discrepancies.