SUMMARY:

• Over 12 years of experience as a Computer System Quality Representative/Reviewer in the Pharmaceutical Industry with comprehensive understanding of GxP Regulations.
• Excellent knowledge of Trackwise Change Control workflow including Initiation, Impact Analysis, Change Planning, Change Execution/Implementation, Task Creation, Change Amendments and Change Control closure phases.
• First rate experience in reviewing quality documents through all phases of Validation Life Cycle including Requirements gathering, validation testing, incident management and change management.
• Excellent experience in representing quality for validating regulated systems like Trackwise (CAPA, Change Control, Field Corrective Actions, Recall Hold workflows), Complaint Management System, Contract Management Software, LIMS, Siebel, Adverse Event Management system, Adverse Event Reporting System, Argus Safety and Scientific Data Management Systems.
• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Expertise in representing quality for both prospective and retrospective validations.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Competent in Quality Systems and Standards (cGxP: cGLPs, cGCPs, and cGMPs) and Regulation of Drugs and Medical Devices.
• Strong Technical Writing background with experience in drafting/issuing User Manuals, Training Materials, Business Requirements and Functional/Configuration/Design Specifications.
• Proficient knowledge of 21 CFR (Part 11, 50, 56, 58, 210, 211, 312, 314, 820) and European regulations.
• Strong background in writing, reviewing and modifying Validation Master Plan (VMP), IQs, OQs, PQs, Validation Summary Reports (VSR), Trace Matrices and Standard Operating Procedures (SOPs).
• Well acquainted with every phase of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC).
• Excellent experience in performing pre and post approval of Test cases (IQ/OQ/PQ) and Defects.
• Extensive experience with Laboratory Information Management Systems (LIMS) and integration with equipment (HPLC, GC, FTIR, Autoclave, Spectrophotometer, pH/EC meter).
• Adept with automated tools such as HP Quality Center (QC), HP Application Lifecycle Management (HP ALM) and Quick Test Professional (QTP).
• Proficiency in developing GAP Analysis, Redemption Plans & designing RTM's
• Motivated individual exhibiting team spirit qualities with excellent communication and interpersonal skills.

PROFESSIONAL EXPERIENCE:

Confidential, Branchburg, NJ

Sr. Validation Analyst

Responsibilities:

• Hands on review of the following deliverables for various Standalone Lab equipment and Spreadsheet systems - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Initiated, maintained and updated requirement traceability matrix to track requirements
• Engaged in initiating, tracking and closing change controls by using Trackwise and wrote deviation reports
• Involved in drafting training manual templates, project planning and document proofs
• Validated the application in accordance to FDA regulations and checked to ensure compliance with 21 CFR Part 11, 820, 210 and 211 requirements
• Prepared, reviewed, executed, and summarized validation protocols (IQ, OQ, PQ) for IT/computerized systems and IVOT’s for Equipment & Automated Systems
• Ensured validation efforts to be conducted in an appropriate and timely manner. Involved in document control and change control management
• Assisted in Ranking the risks associated with functions executed in the system based on the severity of impact to product quality, the probability of a hazard occurring and the probability of detecting a given hazard.
• Conducted design review of all design elements (FS/TS documents) using Design Review checklist prepared from certain Quality Standards.
• Developed a Design Review Plan for all GMP Critical and GMP Non-Critical Requirements in scope of the periodic review.
• Reviewed IQ, OQ and PQ to ensure test cases include adequate test steps/types.
• Trained IT department on computerized system life cycle deliverables and Equipment and automated system deliverables
• Reviewed and verified the Traceability matrix in order to check whether it has been updated regularly and tracing from URS FRS FS TS Test Scripts.
• Engaged in tracking and reporting Change Requests and writing Deviation reports
• Developed, organized and managed multiple tasks with effective time management contributed to review meetings and walkthroughs

Confidential, Raritan, NJ

Sr. Validation Analyst

Responsibilities:

• Helped streamline the process of setting up lab and validated lab equipment as per GCP and GLP guidelines.
• Developed and authored of Standard Operations Procedures (SOP) with the help of Business owners.
• Involved in writing and reviewing the Functional Specification, System Design Specification, System configuration specifications
• Prepared Standard Operating Procedures (SOPs) according to required specifications
• Performed GAP Analysis: assessed the gap and communicated to the management and developed remediation plan
• Authored SOPs and WIs around the GXP processes and various equipment used within the lab.
• Hands on review of the following deliverables for all aforementioned systems - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Provided validation guidance to system Validation team to ensure compliance to FDA requirements.
• Generated flow charts using MS Visio standardized them to clearly comprehend the intricacies of the application so as to better understand the system to be validated.
• Performed GAP analysis to ensure 21 CFR Part 11 compliance and devised Remediation plans
• Authored Qualification Protocols, Test Scripts and User Manuals
• Authored Test scripts to ensure they follow FDA regulations and checked to ensure compliance with 21 CFR Part 11 requirements.
• Conducted periodic reviews and monitored change controls and CAPAs for validated systems.
• Performed pre-approvals and post-approvals on IQ/OQ/PQ test cases and Defects.
• Authored and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.

Confidential, Morris Plains, NJ

Computer System Validation Quality Assurance

Responsibilities:

• Hands on review of the following deliverables for all aforementioned systems - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Reviewed end to end functionality of Trackwise Change Control workflow including Initiation, Impact Analysis, Periodic review, Change Planning, Change Execution/Implementation, Task Creation, Change Amendments and Change Control closure phases.
• Provide validation guidance to system Validation team to ensure compliance to FDA requirements.
• Validated scripts to ensure they follow FDA regulations and checked to ensure compliance with 21 CFR Part 11 requirements.
• Worked extensively on Traceability Matrix to keep track of all the requirements and test scripts.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Logged in Testing Development issues into issue log and verified fixes with development Team
• Reviewed, General Module Test Scripts to ensure compliance with 21 CFR parts 11 with respect to Audit Trail, Data Integrity and Data Security of the application.
• Conducted Manual Testing, developed test cases and wrote Test Scripts for all the functionalities of the application
• Performed pre-approvals and post-approvals on IQ/OQ/PQ test cases and Defects.
• Leveraged HP Quality Center for reviewing, signing off on test cases and Defects.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• Reviewed client SOP’s (Test Execution procedure and Test Defect Report Procedure) and provided feedback.
• Involved in the development of the Information Protection and Risk Management assessment.
• Involved in performing the Quality Risk Assessment of functional specifications.

Confidential, Austin, TX

Quality Reviewer

Responsibilities:

• Reviewed end to end validation documentation for LIMS, Trackwise, Siebel systems to ensure compliance with company policies and procedures.
• Hands on review of the following deliverables for all aforementioned systems - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Reviewed and issued documents using Documentum tool.
• Provide validation guidance to system Validation team to ensure compliance to FDA requirements.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Proficient in GAMP 4 & 5, ISPE Baseline Guide for Commissioning and Qualification.
• Conducted reporting and tracking of defects using Quality Center.
• Developed and maintained Traceability Matrix documents of all systems.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• Involved in the development of the Information Protection and Risk Management assessment
• Involved in performing the Quality Risk Assessment of functional specifications

Confidential, Germantown, MD

Quality Representative

Responsibilities:

• Created, maintained, organized, reviewed and tracked documents using Documentation Compliance Manager
• Worked in concurrence with FDA in a highly regulated environment for all aspects of Computer Systems Validation (CSV).
• Reviewed and updated validation master plan to validate Adverse Event Reporting System (AERS) in compliance with the FDA regulations.
• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Validated AERS to ensure 21 CFR Part 11, electronic records, electronic signatures and cGxP compliance.
• Generated flow charts using MS Visio standardized them to clearly comprehend the intricacies of the application so as to better understand the system to be validated.
• Performed GAP analysis to ensure 21 CFR Part 11 compliance and devised Remediation plans
• Reviewed Qualification Protocols, Test Scripts and User Manuals for Contract Management system and Argus Safety.
• Participated in the preparation of Requirement Traceability Matrix
• Reviewed test scripts and test cases for integration, regression testing and system testing.
• Trained testers on execution of UAT scripts, OQ protocols for accuracy and compliance with the existing SOPs, and incident reporting.
• Authored SOPs for the Validation protocols, system and trained personnel on the systems.

Confidential, Cambridge, MA

Quality Reviewer

Responsibilities:

• Hands on review of the following deliverables for Scientific Data Management, Sharepoint Complaint Trending tool, Siebel and Documentum - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Involved in reviewing User Acceptance Testing (UAT).
• Reviewed test procedures and performed Regression Testing dry runs using the automated tool, Quick Test Professional (QTP)
• Reviewed Validation Summary Report and Disaster Recovery Plan
• Reviewed, documented and helped in the implementation of SOPs
• Developed ways to enforce audit trails, data integrity and data security in analytical equipment.
• Initiated, maintained and updated requirement traceability matrix to track requirements
• Engaged in initiating, tracking and closing change controls by using Trackwise and wrote deviation reports
• Involved in drafting training manual templates, project planning and document proofs
• Validated the application in accordance to FDA regulations and checked to ensure compliance with 21 CFR Part 11 requirements
• Reviewed IQ,OQ and PQ to ensure test cases include adequate test steps/types.
• Developed, organized and managed multiple tasks with effective time management contributed to review meetings and walkthroughs
• Developed Technical Documentation such as technical manuals, data flow diagrams, requirement documents etc.
• Used Quality Center for requirements management and change control management

Confidential, San Antonio, TX

Validation Engineer

Responsibilities:

• Participated throughout SDLC in planning, implementation and documentation of all materials during testing phase
• Developed standard operating procedures based on user and business requirements and ensured that the process was in compliance with FDA regulations
• Gathered requirements for Validation Plan, Test cases and Test Procedures and ensured that the process was in compliance with FDA rules and regulations
• Performed Gap Analysis and also developed the corresponding Remediation plan
• Validated the Electronic Records and Electronic Signatures in accordance with FDA guidelines
• Was involved in designing validation master plan and validation protocols
• Assisted in preparation of validation summary report
• Performed tests on autoclaves for optimal configuration using IQ and OQ detailing on steam checks and temperature maintenance
• Managed system upgrades and maintenance in a cGMP environment
• Maintained the Required Traceability Matrix (RTM)
• Coordinated the validation activities with departments, while providing support services