SUMMARY

• Over 7 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.

TECHNICAL SKILLS

Lab Instruments/ Machines: Agilent Bravo, Perkin Elmer Janus, Perkin Elmer Verispan, Perkin Elmer Envision, Perkin Elmer Enspire, Thermofisher Arrayscan, TTP Labware Arktic, Biotek ELx405, Lifetechnologies EVOS FL Auto, BD Biosciences LSR2, BD Biosciences FACSCaliber, Beckman - Coulter MoFlo XDP

Software: Diva, FlowJo, ModFit LT, Dotmatics, IDBS ActivityBase, GraphPad Prism, SigmaPlot/SigmaStat, LSM and Zen Digital Imaging, IDBS ELN (Electronic Lab Notebook), Accelrys ELN, Empower, Nugenesis SDMS, TrackWise, LabWare LIMS, Labvantage LIMS

Ticket management: Remedy, ServiceNow

Technical Writing Tools: MS Word, MS Excel, MS PowerPoint, MS Visio, MS Project

Content Management: SharePoint, Documentum, QUMAS

Management Tools: MS Project, Clarity

Database: MS Access, MS SQL, Oracle

PROFESSIONAL EXPERIENCE

Confidential, NC

Business Analyst

Responsibilities:

• Reviewed all artifacts of Systems validation lifecycle including Validation Plan and Protocol, Installation Qualification (IQ) Specifications, Operation Qualification (OQ) Specifications, Performance Qualification Specification (PQ), User Manual and SOPS in accordance with company SOP and FDA regulations; particularly 21 CFR Part 11.
• Utilized Documentum based EDMS (Electronic Document Management System) to manage the document work flow.
• Created and maintained Project plan throughout the SDLC using MS Project and RPM.
• Lead JAD discussions to define Validation Plan and Business Requirement Document according to FDA regulations.
• Rigidly followed FDA’s 21 CFR Part 11 to create, modify, maintain, archive and retrieve Electronic records required throughout all the phases of SDLC.
• Developed Test Plan and Test Cases.
• Verified backend testing for compliance with FDA’s 21 CFR Part 11 Electronic Signatures rules
• Developed UAT for the system and performed dry run to find out the issues in system workflow
• Authored IQ/OQ/PQ and coordinated with System Analyst to make sure the system gets qualified through complete IQ/OQ/PQ execution.
• Authored Validation Summary Report and Requirement Traceability Matrix (RTM).
• 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 HPQC.
• Reviewed the requirements for calibration and maintenance, developed as draft procedures and finally issued as authorized Standard Operating Procedures (SOPs) as part of the SOP program of the company.
• Organized the daily operations of the validation group to assure that master plans, protocols, and reports are generated and approved within predetermined timelines.
• Documented Installation Guides and training manual.

Confidential, Weston, FL

Business / Validation Analyst

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, NJ

Business Analyst

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

Confidential, CA

Business Analyst

Responsibilities:

• Identified, researched, investigated, realized, analyzed, defined and documented current business process model and desired business process model.
• Created complex Use Cases, Business Processes and Work Flow Diagrams using MS Visio and MS Excel.
• Developed number of SDLC deliverables including Business Requirement Document, Validation Strategy Document, System Design Specifications, User and Functional Requirement Specifications, IQ/OQ/PQ, SOPs/Work Instructions and Validation Summary Reports
• Assisted Project Manager in resource management, scoping and planning of validation activities
• Developed Test Cases for Integration Testing
• Developed UAT Test Cases and performed ‘Dry Run’.
• Performed Gap Analysis and GxP Impact Assessments, Periodic Assessments, 21 CFR Part 11 Assessments and Internal Auditing
• Provided immediate solutions for the special situations during implementation of the various systems
• Participated in developing templates, SOPs and training material

Confidential, NC

Business Analyst

Responsibilities:

• Documented User Requirements from users and prepared Functional Requirement documents that for various laboratory systems.
• Created Swimlane Diagrams, and Process Flows and Data Flow diagrams using Microsoft Visio.
• Created Use Cases to ensure reliable results of implemented business/functional processes.
• Responsible for ensuring all documents and procedures comply with the Company’s validation guidelines as well as industry standards.
• Performed Vendor Assessments and reviewed vendor documents in order to ensure compliance to the company policy and validation requirements.
• Provided subject matter expertise in areas including project management, project scope definition, risk identification, project methodology, resource allocation, facilitation, and other areas of expertise based on professional knowledge and background.
• Developed Test Plan, Test Cases, Test Scripts.
• Developed and maintained RTM to keep track of changing requirements.
• Maintained SOP in compliance with 21 CFR Part 11.
• Validated all phases of system life cycle as required by FDA regulations under 21 CFR Part 11 (Electronic Records and Electronic Signatures).

Confidential, IL

Validation Analyst

Responsibilities:

• Worked with scientists and SMEs to understand laboratory process flows.
• Develop use cases, user stories and business process flows to guide technical teams for solution implementation.
• Gathered business requirements by working with scientists
• Executed IQ and OQ protocols for various laboratory applications.
• Prepared Validation Summary Report and worked with Quality Assurance group in approval of SDLC deliverables according to GAMP guidelines.