SUMMARY

• More than 8 years of accumulative Validation Analyst / Quality Assurance or Technical Writer experience with complex Information Technology systems in Pharmaceutical domain/Medical Device/Tobacco Industry.
• Diverse accumulative experience with Quality Analysis, Computer System Validation Analysis and Technical Writing for various Pharmaceutical and Clinical Research Organization.
• Possess profound knowledge of Clinical research, CAPA, FDA regulations, 21 CFR part 11, Electronic Records/ Electronic Signatures, cGXP’s (GLP, GCP, and GMP) and GAMP
• Strong skills for Quality Assurance, Validation Analysis, Auditing and Technical Writing.
• Extensive experience in working on various test strategies and preparing Test Plans, Test Cases and Analyzing Test Results.
• Hands on experience with setting up QA environment, generating manual test scripts, performing various testing such as unit testing / functional testing / regression testing / integration testing / black - box testing and user acceptance testing
• Extensive experience on writing documents such as URS, GxP Risk Assessment, Part 11 Assessment, Project Validation Plan, Test Strategy, Training Plan, FRS (Functional Requirements Specification), SDS (System Design Specification), SCS (Software Configuration Specification), IQ, OQ & PQ, Defects & Deviation Report, Trace Matrix, Execution Summary Report, Final Quality Summary Report (Quality Summary Report), SOP and Work Instructions.

TECHNICAL SKILLS

Regulations: ICH, MHRA, 21 CFR Part 11, GXP

Web Technologies: HTML, JSP

OS: Windows 95/98/NT/XP/Windows 7

Software: BPCS LX (Enterprise Resource Planning),LWLIMS(Lab Ware LIMS), Agile PLM, EDC (Electronic Data Capture System), Serena Business Manager (SBM- Change Control), Application Lifecycle Management (ALM-V11) Master Control (Core, Documents, Portal and Training), Interspec - Specifications, Interspec Interfaces ETL, Beamex Calibration Software, Genealogy Trace Tool, Service Now (Change Control), Consumer Complaints, Microsoft Office Suite, MS Visio, Documentum, SharePoint, eRoom, Track Wise, Bug Tracker, Clear Quest.

Testing Tools: HPQC, HP ALM

Databases: Microsoft Access and MS SQL Server

PROFESSIONAL EXPERIENCE

Confidential, NC

Computer System Validation Engineer

Responsibilities:

• Created, Proofread, modified, maintained, archived and retrieved technical documents with the help of SharePoint
• Responsible for managing document work flow in SharePoint as per the company SOP.
• Created GxP Risk Assessment, GxP Relevancy Assessment, Part 11 Assessment document & Functional Risk Assessment.
• Authored User requirement Document, Functional Requirement Document, Design Document & Software Configuration Specification.
• Facilitated discussion to define system criticality according to FDA regulations and performed risk assessment to create Project Validation Plan, Test Strategy and Data Migration Plan.
• Authored and Reviewed test scripts for IQ/OQ/PQ and coordinated with testers to make sure the system gets qualified through complete IQ/OQ/PQ execution.
• Performed dry run to find out the issues in system before the final UAT execution.
• Performed IT and UAT testing regularly in HPALM (v 11.0) by manual.
• Trained Testers prior to Execution.
• Acted as Validation Proctor/Test lead during the script execution to help the testers on how to file defect or deviation.
• Managed bug tracking cycle in ALM 11 with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.
• Generated Bug Report showing Nature of Error in terms of Minor, Major and Critical and developed matrix report using HPALM.
• Generated IQ, OQ, and PQ report using HPALM.
• Created IQ Deviation Report, OQ Deviation Report & PQ Deviation Report.
• Authored IQ Summary Report, OQ Summary Report, PQ Summary Report and Quality Summary Report and Requirement Traceability Matrix (RTM).
• Authored Detailed Test Summary Report & Quality Summary Report.
• Authored and Reviewed SOPs and Work Instructions.
• Conduct interviews of new candidates.

Confidential, PA

Computer System Validation Analyst/ System QA Analyst

Responsibilities:

• Work as a Validation QA Analyst for LabWare LIMS and various other IT systems to assess compliance risk status against FDA guidelines and participate in Computer System Validation and QA activities
• Prepare / Review various computer system validation artifacts such as Validation Plan, Installation Qualification, Operational Qualification, Performance Qualification, Quality Summary, Requirement Traceability Matrix
• Develop User Acceptance Test (UAT) scripts for the computer system testing and perform dry run to find out the issues in system before the final UAT execution.
• Authored QA Summary Report and Managed bug tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during IT and UAT testing in HPQC.
• Authored Test script, Requirement document, Design document and other Qualification document in HPQC.
• Performed IT and UAT testing regularly in HPQC (v 11.0) by manual.

Confidential, MA

Compute System Validation Analyst / Technical Documentation Writer

Responsibilities:

• Performed GAP Analysis of various IT systems to assess client’s current compliance status against FDA guidelines.
• Created, Proofread, modified, maintained, archived and retrieved technical documents with the help of SharePoint
• Responsible for managing document work flow in SharePoint as per the company SOP.
• Reviewed Business requirement Document and Functional Requirement Document.
• Facilitated discussion to define system criticality according to FDA regulations and performed risk assessment to create Quality Assurance Plan and Data Migration Plan.
• Authored and Reviewed test scripts for IQ/OQ/PQ and coordinated with testers to make sure the system gets qualified through complete IQ/OQ/PQ execution.
• Developed UAT scripts for the system testing and performed dry run to find out the issues in system before the final UAT execution.
• Managed bug tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.
• Generated Bug Report showing Nature of Error in terms of Minor, Major and Critical and developed matrix report using HPQC.
• Authored QA Summary Report and Requirement Traceability Matrix (RTM).
• Verified backend testing for compliance with FDA’s 21 CFR Part 11 Electronic Signatures rules

Confidential, PA

Compute System Validation Analyst / Quality Assurance Analyst

Responsibilities:

• Project was to perform system validation for computer based Data Capture System designed to accelerate and simplify the collection of clinical data and the deployment of EDC studies at clinical trial investigative sites.
• Responsibilities included requirement analysis; test planning, test design, test data preparation, test execution, result analysis, bug tracking, quality assurance and client support.
• Analyzed the user/business requirements, functional specs and use case documents to create test cases for Unit Testing, Integration Testing and User Acceptance Testing (UAT).
• Coordinated with the business analysts and developers for interpreting the requirements.
• Performed Positive & Negative Testing
• Involved in developing Entry & Exit criteria and defined the pass and fail standards.
• Created regression test cases.
• Executed the Test Cases and Test Sets in Quality Center (HPQC) to verify the expected results.
• Used Quality Center to store and maintain the Test Repository.
• Interacted with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution with the help of ClearQuest.
• Worked with QA lead to develop the Requirement Traceability Matrix (RTM) for future references and audit trail.
• Extensively used SQL queries to verify backend data.
• Active participant of project meetings, release meetings, and QA status meetings.

Confidential, NJ

Production Associate / QA Analyst

Responsibilities:

• Participated in production line management and, manufacturing of pharmaceutical products with strict adherence to established procedures including cGMP
• Executed and reviewed Batch Manufacturing Record
• Authored / reviewed SOPs and other Documents related to Validation.
• Understood cGMP procedures and worked with Quality Assurance, Validation, and Regulatory departments to ensure compliance.
• DEA (Drug Enforcement Administration) floor supervisor, for compliance of controlled drug moments.
• Provided training to new manufacturing employee to make sure personal trainee compliance to the standards.
• Responsible in the operation like Manufacturing, Filling, Packaging and Labeling.
• Good knowledge of documentation required in production area (e.g. Batch preparation, filling operation etc.)
• Set up/assemble machines as well as dissemble machines and also good knowledge of cleaning machines.
• Good knowledge of maintain documentation required in Batch preparation, filling and other production operation.

Confidential

QA Analyst

Responsibilities:

• Performed GAP analysis for company’s current compliance status against FDA guidelines.
• Authored and Reviewed Business requirement and Functional requirement document.
• Authored Test Plan and Test Cases.
• Authored System Risk Assessment document and Part 11 document.
• Validated all phases of system life cycle as required by FDA regulations under 21 CFR Part 11 (Electronic Records and Electronic Signatures).
• Created Validation plan based on the initial analysis of system requirements.
• Validated Change control document.
• Validated Functional requirement document and Design specification document.
• Performed Vendor assessments and reviewed
• Authored draft procedures for calibration and maintenance and finally issued authorized Standard Operating Procedures (SOPs).
• Authored test scripts for IQ/OQ/PQ and coordinated with testers to make sure the system gets qualified through complete IQ/OQ/PQ execution.
• Developed UAT scripts for the system testing and performed dry run to find out the issues in system before the final UAT execution.
• Managed bug tracking cycle with daily release calls with developers and various members of team to discuss and resolve defects arose during the UAT (User Acceptance Testing) execution.
• Authored QA Summary Report and Requirement Traceability Matrix (RTM).
• Verified backend testing for compliance with FDA’s 21 CFR Part 11 Electronic Signatures rule