SUMMARY:

• 7 years of experience with Information Technology Systems in FDA regulated industries with emphasis on Business Analysis, Project Management, Validation and Quality Assurance.
• Solid experience in validating and deploying various instrument systems, laboratory and research applications.
• Strong understanding of FDA regulations, 21 CFR part 11, Annex 11, 21 CFR 820, USP 1058, Pharmacovigilance, Electronic Records/ Electronic Signatures, cGXP (GMP, GLP, GCP), ISPE, GAMP 4, GAMP 5, MHRA, ISO9001, ITIL and ICH.
• Specialist in authoring and reviewing validation artifacts such as Change Request, Requirement Specifications, Validation Master Plan, Design Specification, Traceability Matrix (RTM), UAT, Qualification Protocols (IQ, OQ, PQ),Validation Summary Report, Standard Operating Procedures (SOP), User Guide and Manual.
• Extensive knowledge of Software Development Life cycle (SDLC) methodologies including RUP, Waterfall and Agile.
• Possess strong suits of business analysis skills which includes Gap Analysis, ‘As is’ and ‘To be’ Analysis, ROI Analysis, Project Coordination, Requirement Gathering and Business Communication.
• Strong visualization skills for preparing Process Flow, Data Flow and Activity Flow diagrams using MS Visio.
• Superior skill in data collection, tracking, analysis, interpretation, graphical representation, and presentation.
• Experience in designing User Cases, User Stories, developing and maintaining Test Scripts, analyzing defects and interacting with development team members in fixing the defects.

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, NJ

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 manual.

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, PA

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 material

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.