SUMMARY:

• Over 5 plus Years of Experience in Software Validation and overall 7 plus years in Testing processes.
• Understanding of drug development process and sound knowledge of FDA, GCP, GLP and GMP requirements, predicate rules 21 CFR Part 11, Annex 11.
• Understanding of teh principles of Computer System Validation, Periodic Review, and both Internal and External Audits. Working knowledge of GAMP 5 systems.
• Experience in Software Quality Assurance Methodologies.
• Experience in execution of IQ/OQ/PQ protocols.
• Experience in Quality/Regulated environment and implementation of Quality Systems for software adhering to FDA standards.
• Implementation of quality systems in line with SDLC requirements and developing Validation Risk Assessment Plan/Summary Reports.
• Participation in implementation of 21 CFR Part 11 - Electronic Record and Electronic Signature requirements, Security, Audit trail (user and date time stamps), Validation, Development Methodologies, Requirements, Design, Testing Methodologies in UT/IT/UAT phases.
• Participation in creation of SOP’s, Validation Plans, and software inspection/audits.
• Development of requirement guidelines specification documents, design specification documents, project activities summary documents, trace ability/verification matrix, technical standards documents, Master validation plans for UT/IT/UAT test phases.
• Good experience in Database Testing, Ad-hoc testing, Security Testing and System Testing.

TECHNICAL SKILLS:

Operating System: Windows and UNIX.

Languages: SQL, HTML, CSS.

Databases: Oracle 8.0, SQL Server7.0 and MS Access.

Software Packages: MS Word, Excel, Power Point, Outlook, Serena Business Manager/Tracker and Internet Services

Test Tools: QTP and Quality Center.

Others: GCP, GMP, GLP, HPLC systems.

PROFESSIONAL EXPERIENCE:

Confidential, New Brunswick, NJ

Validation ANALYST

Responsibilities:

• Attend workshops for business requirement gathering for teh Clinical Trial Management System to be used globally at sites.
• Worked on creating and approving scripts in HP quality center.
• Change Control Management, Planning and Execution using Remedy suite of products.
• Worked on creation, updation and review of validated documents using Documentum.
• Assist in creating a harmonized clinical business workflow to be followed by all clinical areas within teh firm.
• Assist in teh review teh Requirements Specifications document to verify business requirements and regulatory requirements are documented accurately.
• Responsible for authoring teh Validation deliverables as defined in teh SDLC me.e. System Validation Plan, Test Plans, Test Scripts, Summary Reports, Traceability Matrices, etc.
• Track project milestones and outstanding issues to present to teh team including upper management.
• Provided overview of SOPs and system application to project team and teh business unit.
• Successfully assisted in leading teh User Acceptance Testing efforts.
• Responsible for documenting system variances with Corrective Actions and Preventative Actions.
• Responsible for authoring teh following documents for teh Clinical Trial Reporting Tool: Validation Plan, Risk Assessment, Traceability Matrices, Summary Memos and Validation Test Summary Report.
• Successfully lead teh User Acceptance Testing efforts.
• Responsible for documenting system variances with Corrective Actions and Preventative Actions.
• Created and revised applicable validation documentation such as Validation Strategy Document, Test Plans and Test Scripts, Summary Reports, User Requirements, Retirement Documents, Standard Operating Procedures, etc for legacy systems.
• Support Management with teh remediation of system validation and equipment qualification for teh international project sites.
• Report assessment findings and recommend remediation strategies for compliance gaps.
• Author teh Remediation Closeout Summary reports for systems where teh remediation activities were completed.
• Assist in presenting validation deliverables and answering questions during audits of teh Part 11 Remediated Systems.
• Perform GxP Regulatory Assessments to identify regulated systems and equipments.
• Assist in Equipment Qualification in teh GLP labs.
• Perform Periodic Reviews of GxP systems to verify they have remained in a validated state since in production and close out issues identified in teh Periodic Reviews.

Confidential - NJ

Quality Assurance

Responsibilities:

• Reviewed teh Equipment Qualification Plan, Installation Operational Performance Qualification Plan and Protocols, Computer System Validation Plan, User and Functional Requirement Specifications, Design Specifications, Test Plans, Test Protocols and Summary Reports, etc..
• Assured dat teh principles of teh SDLC process are followed.
• Provided guidance in Federal Regulatory Requirements GMP 210, 211, 21 CFR Part 11 and standard operating procedures.
• Provided technical expertise for computer system validation and equipment qualification in teh manufacturing and laboratory areas.

Confidential - PHILADELPHIA, PA

Validation Analyst

Responsibilities:

• Participated in gathering and writing teh user and functional requirements for teh application. Assisted teh developer in teh configuration of systems.
• Responsible for writing teh Validation Strategy Document, System Test Plan and test scripts, Traceability Matrix, and teh Summary Reports in accordance to SOP’s, and 21 CFR Part 11.
• Responsible for performing quality reviews on documentation created by teh developers on teh team me.e. System Design Specification and IQ/OQ.
• Responsible for project documentation storage in Documentum and Dimensions.
• Revised teh User and Functional Requirements document to make each requirement testable and unambiguous.
• Assisted in writing test scripts to test against new requirements added to teh User and Functional Requirements document.
• Created teh Retrospective Evaluation Report using teh information gatheird from teh research to ensure teh integrity of teh data before migrating teh data to BioLIMS, Release 2.

Confidential - Basking ridge, NJ

QA Lead

Responsibilities:

• Developed Environment Test Plans, Environment Test Completion Reports, Regression Test Plans, and Regression Test Completion Reports for each of teh validated systems.
• Ensure dat all development and test documentation are within teh company’s standard procedures as well as regulatory predicate rules.
• Managed 7 testers.
• Gatheird detailed testing information from teh system owners of teh applications.
• Assisted Project Manager with timelines for testing.
• Assisted Project Manager with teh planning/strategies for teh Oracle 8i migration.
• Developed teh Unit Test Plan, Integration Test Plan and Integration Test Scripts for teh E2B project.
• Successfully lead teh Testing efforts.
• Tracked testing through teh use of a test execution matrix.
• Tracked defects through an excel matrix spreadsheet.

Confidential - Basking ridge, NJ

QA Analyst

Responsibilities:

• Developed test plans to support client based systems.
• Developed and executed software test cases in Oracle, Sybase, and NT.
• Performed teh following quality assurance testing in UNIX using both Oracle and Sybase databases: Base testing, System testing, on-site support UAT testing, and Regression Testing.
• Documented and validated all programming bugs in SQA Manager.
• Reviewed functional and programming specifications.
• Built engine connection, and factory servers using Unix and ran batch cycles.

Confidential

Quality Analyst

Responsibilities:

• Developed and executed test cases for system testing.
• Implemented and performed required software validation testing.
• Software Liaison to Technical Services Representatives and clients both in teh US and International.
• Troubleshoot operating software for medical device on a Windows NT platform.
• Administrator for teh defect tracking device Bug Base.
• Assigned bug fixes to programmers and validated teh fixes.