Summary:

• Over 8 years of diversified experience as a Business Analyst in the pharmaceutical industry, known for the ability to develop and implement processes that positively impact the compliance results
• Thorough understanding of the Software Development Lifecycle and Validation Lifecycle with the emphasis on the manual and automated testing
• Creating user requirements document by interacting with the end users and developers
• Knowledge and working experience in GLP, GMP and GCP suites
• Participation in 21 CFR Part 11 and GxP compliance assessments.
• Extensive experience in preparing and executing qualification protocols (IQ, OQ, PQ)
• Proficient in dealing with Standard Operating Procedures (SOPs), Test plan, Laboratory information management system (LIMS).
• Knowledge of industry practices and regulatory expectations as they relate to commissioning, qualification, and validation programs.
• Quality and detail oriented, ability to interact with all levels of the organization and influence decision making.
• Expert in Requirement Analysis / System Specification Analysis.
• Participation in 21 CFR Part 11 compliance assessments.
• Implementation of 21 CFR Part 11 regulations.
• Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current pharmaceutical industry standards.
• Good understanding of statistical design of experiments, process capability analysis, FMEA, FTA hazard analysis, failure analysis and six sigma tools.
• Excellent communication and documentation skills in the field of technical writing.

Software Skills:

Testing Tools:

Bug Reporting Tools:

Bugzilla, Test Director

Operating Systems

Windows XP, OS/400, MVS, UNIX

Hardware:

IBM PC, AS/400, Dell and Sun

RDBMS:

Oracle, MS Access, SQL Server, DB2

Web Technologies:

HTML, XML

Web Browsers:

Netscape, Internet Explorer 5.5

Other Tools:

Microsoft Office, Documentum, Watson LIMS, Lab Vantage LIMS, Labware LIMS, SAP R/3,ELAN

EXPERIENCE:

Confidential(Sept’09 to Present)
Thousand Oaks, CA

Project: Watson Laboratory Information Management System Validation.

Responsibilities:

• Worked as Watson LIMS Business Analyst which is used for Pharmaco Kinetics Drug Metabolism (PKDM) studies.
• Actively involved in discussion with ‘Small Molecules’ and ‘Large Molecules teams’ in analyzing the business requirements and convert them into functional requirements.
• Translated Business requirements into user Documentations.
• Gathered business requirements and participated in the designing of the Validation Master Plan (VMP) and Testing Criteria.
• Authored Amgen Specific End-To-End test scenarios to test complete business process for ‘Small Molecules’ and ‘Large Molecules teams’ which involves different instruments are interfacing with Watson LIMS.
• Worked with Thermo team in developing Design Specification document.
• Designed and authored validation protocols for Watson LIMS application
• Organized and maintained documents like Requirements Traceability Matrix (RTM) and Test Strategy
• Developed, analyzed and reviewed test scripts to check the functionalities of the application for 21CFR part 11 compliance.
• Authored IQ’s for installation Watson LIMS
• Worked closely with Thermo team in producing and executing all required documents.
• Created and tracked deviations occurred during testing process.
• Reviewed IQ/OQ/PQ’s
• Ensured the execution of UAT test cases and documentation of the test results

Project: PKS

• Liaised with lead business users (PK Analyst, QC Coordinator/QC Reviewer) and developed system process flows and User Requirements Specifications.
• Identified key work streams for testing based on risk analysis.
• Authored OQ and PQ test scripts to challenge all regulatory and security requirements.
• Identified critical functionalities used by the users for OQ testing.
• Led/facilitated Client Acceptance testing (OQ) with a group of 13 system users (PKDM and IS) across multiple sites.
• Performed review of OQ test executions and created fault reports and deviations as required.
• Authored responses to audit findings.
• Led/facilitated Performance Qualification with on site and remote site system users.
• Authored OQ test scripts for SAS Clinical Connector, Watson Connector.
• Involved in Authoring of Requirement Traceability Matrix for PKS
• Performed Non Compartmental Analysis on SAS data set using WinNonlin

Confidential (Nov ’08 to Sept’09)

Project: Laboratory Information Management System Implementation and Validation.

Responsibilities:

• Involved in validation of Labware LIMS system rollout project.
• Developed Validation Strategy and documented in Validation Plan.
• Prepared Operational Qualification and User Acceptance Test Plans.
• Wrote and executed Operation Qualifications and Process and Product Validations.
• Involved in development, review and execution of validation documents, generating and executing SOPs and protocols, conducting testing, and preparing final summaries.
• Developed Requirement Traceability Matrix and Risk Assessment documents.
• Prepared Deviation reports as part of OQ testing and kept track of all deviations occurred.
• Developed Test Summary Reports and Validation Summary Report.

Confidential(Mar ‘07 Oct’ 08)
Collegeville, PA

Responsibilities:

• Analyzed business requirements and developed test plans, test cases to cover overall quality assurance system testing.
• Involved in Change Control Processes to keep track of all the changes made to the validated environment.
• Developed Master Test Plan and system test scripts for an Oracle Clinical upgrade project as part of computer system validation.
• Involved in validation of Oracle Clinical business processes in accordance with EMEA and FDA regulations.
• Developed Operational Qualification Test Plan and documented OQ test strategy.
• Involved in preparation of Operational Qualification (OQ) test scripts as part of OQ test cycle.
• Worked closely with QA team to identify the test scenarios and test cases.
• Included negative test steps in the test scripts to challenge the system against system requirements.
• Developed test summary reports to summarize the test results according to company Standard Operating Procedures.
• Developed test scripts to ensure that the system is compliant with 21 CFR Part 11 and GMP regulations.
• Documented deviation reports and maintained deviation report log for tracking during OQ testing.
• Developed Performance Qualification (PQ) Test Plan and documented PQ test strategy and test scope.
• Participated in change control process meetings with business users and developers.
• Prepared test scripts for data base updates and audit trials.

Confidential(May ‘06 Mar’07)
Ardsley, NY

Responsibilities:

• Analysis of the Functional Requirements for Bio-Analytical Watson LIMS.
• Writing of OQ scripts for modules-Assay Design, Plan Analytical Runs, Study Design, Study Configuration, Bi-Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in Watson LIMS
• Executed IQ, OQ and PQ testing protocols for Watson LIMS and Labware LIMS
• Validating the Water’s Millennium Interface with Watson LIMS
• Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts.
• Involved in conducting Performance Qualification (PQ) to test the performance of the system according to business requirements.
• Developed User Acceptance Test Plan (UATP) and User Acceptance Test Summary Report for UAT test cycle.
• Involved in validating all Network Devices that are interacting with Lab Instruments
• Conducted routing Internal inspections of regulated systems (GMP, GCP, GLP) to assure validation procedures have been followed in compliance with company, divisional and departmental policies and predicated rules.
• Involved in developing and co-coordinating with team members to develop Validation Summary Report (VSR).
• Involved in meetings with users to develop Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).
• Involved in Dry run applications before validated testing phase.

Confidential, NJ (May’05 Apr ’06)

Responsibilities:

• Involved in preparing Master Validation Plan for SAP R/3 system implementation.
• Prepared Validation Plan for every project implementation and involved in full cycle validation throughout all phases in SDLC.
• Developed Validation/SDLC Deliverables including User Requirements and System Requirements Specification documents (URS & SRS).
• Worked with SAP functional team to validate the transactions and modules to be complaint with 21 CFR Part 11 and GMP regulations.
• Experienced in testing Lab vantage LIMS system, which is an Laboratory Information Management System involving functional and user-acceptance testing.
• Involved in development of Master Test Plans and Test Scripts in OQ and PQ/UAT.
• Involved in Pre-execution review of OQ and PQ/UAT scripts and incorporated negative test steps to challenge the system. Also involved in Post review to verify the compliancy and documentation of scripts according to GDP regulations.
• Conducted Gap Analysis to demonstrate that LIMS System remains in a validated state in its life cycle.
• Prepared Traceability Matrix to keep track of relationship between all requirements and test scripts.
• Prepared Qualification Reports to qualify Barcode printers in manufacturing process.
• Validated a web-based application in accordance with GMP regulations, which is used in manufacturing processes.
• Prepared Test Summary Reports and Validation Summary Report to summarize all the activities performed during system validation.

Confidential, Raritan, NJ (Feb ’04 to Apr ‘05)

Responsibilities:

• Analysis of the Business requirements and Performance requirements of the medical instruments and associated software, validating their functional performance according to FDA, ISO 9000, IEEE and Corporate Standards.
• Responsible for providing technical expertise regarding commissioning and qualification of the Texas, software, systems and equipment.
• Participation on software project teams to review and analyze software documentation/project deliverables associated with the Software Development Lifecycle.
• Developed the validation test plans for quality assurance of the medical instruments in accordance with regulatory standards.
• Generation of test protocols for software testing and validation.
• Responsible for executing and developing compatibility validation tests.
• Perform statistical analysis, process capability analysis, FMEA, FTA (Fault Tree Analysis) hazard analysis.
• Developed test plans, test protocols for software enhancements and changes.
• Provide technical support for commissioning activities (e.g. receipt verification, factory acceptance testing, functional testing, etc.).
• Provide support for qualification activities (e.g. Design Qualification, Installation Qualification and Operational Qualification) as the system is developed and installed.
• Performed integration, interface and system testing.
• Performed load testing on the OAS server, which is connected to the OSP Instrument.
• Interacted with developers to fix the software defects.
• Provided Support and Technical training to Users Group.

Confidential, NJ (Jan ’02 Jan ‘04)
QA Analyst

Responsibilities:

• Involved in analyzing system specifications, design and development of test plans.
• Analyzing business requirements to develop functional and detail design specifications of the application.
• Implementation of test plans based on business requirements technical and specifications and interactions with Business and System Analysts.
• Identified, developed and executed Test Cases Manually.
• Involved in conducting stress test and volume test against the application.
• Conducted Performance testing, Multi user testing and Regression testing.
• Executed SQL queries to validate application results with database results.
• Customized Help and prepared the user guide for the GSSP application.
• Developed and conducted system and user acceptance tests on completion of system testing before installation of the application on user environment.
• Implemented SEI CMM, ISO and IEEE standards throughout the Quality Assurance Life Cycle and documented the entire Testing Process in MS Word.

• Bachelors in Mechanical Engineering