SUMMARY:

• Eight years of experience in Validation with strong background in Computer System Validation, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP).
• Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy.
• Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Pharmaceutical/Biotech manufacturing.
• Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations.
• Experience in utilities and facilities qualification, equipment qualification, and computer validation.
• Experience with Factory Acceptance Test (FAT).
• Good understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5 and associated FDA, GCP/ICH guidelines.
• Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, IQ/OQ/PQ/RTM, and validation reports.
• Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Experience in using quality center to manage testing artifacts.
• Performed GAP analysis in identifying compliance gaps.
• Developed and implemented corrective action and preventive action plans (CAPA).
• Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Excellent knowledge and experience in configuring and validating StarLIMS, SQL *LIMS
• Developed interfaces with laboratory instruments using StarLIMS Scripting Language
• Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Strong hands on experience in using Win Runner, Load Runner and Test director.
• Ability to work both independently and in a team-oriented working environment.

TECHNICAL SKILLS:

Tools: Quality Center, MS Office Suite Word, Excel, PowerPoint, Outlook, MS Visio, MS Project.

Operating System: Windows/Vista

Methodologies: Waterfall, V-Model, Spiral, and Agile.

FDA Regulations: 21CFR Part (cGMP’s),GAMP 5, 803 (Medical Device Reporting), 820 (Quality System Regulation).

Validation Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report.

Laboratory Equipments: Gas chromatography/Mass chromatography (GC/MS), Liquid chromatography(LS), Scanning Electron Microscope.

PROFESSIONAL SUMMARY:

Confidential, New Brunswick, NJ

CSV Engineer

Responsibilities:

• Responsible for generation of full life cycle validation documents (GAP Analysis, GxP Assessment, Simple/Complex System Assessment, Requirement checklist, As Is Functional and Design Specifications, User and Functional Requirements, DDS, Remediation Plan, System Test Plans, RTM, Validation and Test Summary Report, Document Index Registry, SOPs) for legacy and new systems.
• Validation of HPLC (High Performance Liquid Chromatography) laboratory systems
• Validation Plan for similar 6 HPLC systems of laboratory systems which were integrated with Empower
• User and functional requirements with Part 11 Functionalities
• Responsible for testing strategy, Test Plan & Protocol, IQ, OQ, PQ, RTM, and Validation Summary
• Plan the validation effort based on risk assessment and regulatory assessment
• Provided inputs for writing Computer Work Instructions
• Validation of Total Organic Carbon Analyzer (TOC) laboratory systems
• Responsible for User and functional requirements with Part 11 Functionalities
• Responsible for Test Plan & Protocol, IQ, OQ, PQ, RTM, and Validation Summary
• Validation of FTIR (Fourier Transform Infrared Spectroscopy), UV/Vis laboratory systems
• Authored the deliverables - Validation Plan (VP), Requirement Specifications, Test Plan and Protocol, Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR)
• Periodic Review of various laboratory and enterprise systems
• Reviewed Performance Monitoring Plans, Quarterly Performance Monitoring Summary Report
• Reviewed Validation deliverables, Change Control Logs, Production Log, Event Log, Platform Log, Database Change Logs
• Performed Risk Assessment
• Review SOPs / Computer Work Instructions (CWI) / Laboratory Equipment Procedures (LEP) against business use, local policies / procedures, and regulations
• Review user training log, user log, user manual, technical support manual, calibration records and preventive maintenance records
• Advised on bringing systems to complete compliance
• Summarize the review and recommendations in Periodic Review Report
• Performed Periodic Review on Ab Initio (Data Warehousing tool), SAS Tool, Excel Spreadsheets, Spectrophotometers, Particle Size Analyzers

Confidential, Menomonie, WI

CSV Engineer

Responsibilities:

• Support cGMP program including: Risk Analysis, Change Control, and Standard Operating Procedure using QUMAS. Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.
• Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with Regulation and participated in preparing the implementation plan.
• Extensive experience on Test Method Validation (TMV) for attribute and variable and analytical test methods.
• Working with the validation team leader, created the customer specific Equipment Installation and Operational Qualification Protocol (IOQ) standardized template, along with the templates for the Process Operational Qualification Protocol (OQ) and the Performance Qualification Protocol (PQ), intended for Phase I, II, Clinical Trials and Phase III of the Pilot Program development process.
• Documented, reviewed and approved 21 CFR Part 11 Assessment and GxP Risk Assessments.
• Maintained Requirement Traceability Matrices in Excel Spreadsheets to track requirements and correlate them with the conducted test cases.
• Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.
• Created and Reviewed Change Control Plan, Quality validation plan, Risk Analysis Plan.
• Participated in all the activities of preparation of Validation Plan to Validation Summary Report of involved systems software.
• Participated in Change Management meeting and reviewed CCs from Validation Standpoint.
• Documented and reviewed Installation Qualification Protocols, Operational Qualification Protocols and Performance Qualification Protocol.
• Ensured adherence by staff to quality, regulatory and GxP standards.
• Involved in all phases of SDLC according to Company procedures, FDA Guidelines, GMP.
• Performed V & V for all approved product contacted areas and product/process materials used.
• Authored and Executed IOQ, OQ and PQ protocols for a variety of automated assembly systems and on-line inspection and test systems, inclusive of software and/or firmware/hardware and PLCs systems.
• Created documents such as PFMEA, MVP, TMV, IQ, OQ, PQ etc.
• Received Company correspondence expressing appreciation for accomplishment contributions made.

Confidential, Malvern, PA

Validation Engineer

Responsibilities:

• Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.
• Change control Procedure and Testing SOP’s.
• Gathered User Requirements from Business process owners.
• Reviewed URS (User Requirements Specification).
• Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification) documents.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with GxP FDA Compliance Regulations.
• Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Test Cases for Functional and Regression Testing.
• Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.
• Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.
• Created Risk assessment and Quality validation plan for the whole project.
• Scheduled and ensured timely completion of validation activities.
• Wrote summary reports for qualification protocols.
• Conducted audits to determine the Validation status of systems in various departments.
• Report results from audits to upper management and assist in corrective action plans.
• Ensured that the system is following the 21 CFR part 11 electronic records and electronics signatures regulatory standards which included automatic date-time entry, multi-level password security and secure system sign-on features.

Confidential, Canton, MA

Validation Analyst

Responsibilities:

• Involved in Validation of Lab Instruments (FTIR (Fourier transform infrared spectroscopy) & HPLC Shimadzu Series)
• Involved with Risk Analysis and prepared and reviewed remediation Procedures, Test cases & Validation Summary Reports
• Analyzed as is functional specifications and requirements to categorize the units.
• Developed SOPs, System Admin., and Instrument Operating Procedures.
• Developed Protocols IQ, OQ and PQ
• Involved in the design and implementation of data collection, analysis and validation using MS-Access and MS Excel.
• Developed User Acceptance Protocol to describe the specific objectives, procedures, data sets, test scenarios, expected results, and acceptance criteria for the PQ/ UAT process
• Used authority checks to ensure that authorized individuals can enter, sign or change data
• Involved in writing protocols for stress testing and performance testing
• Involved in the execution of Test Protocols (IQ, OQ and PQ)
• Participated in all Project Meeting and involved resolution of various issues
• Maintained Requirement Traceability Matrices in Excel Spreadsheets to track requirements and correlate them with the conducted test cases.
• Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.
• Created and Reviewed several Change Controls for Quality validation plan, Risk Analysis Plan.
• Involved in the preparation of Validation Plan to Validation Summary Report of involved systems software
• Developed IQ, OQ, PQ protocols and Involved in full Validation Development Life Cycle.
• Support and Review of validation documentation and external/internal audits.
• Performed peer reviews of project validation records, provided feedback on gaps and needed improvements as required to meet validation SOP and Standards.
• Involved in documentation/Review of Lifecycle development and SDLC processes