SUMMARY

• 5+ years of experience as Product Analyst / Product Engineer in a pharmaceutical/biotech corporate environment. Experience in communication with all level of management.
• Hands - on experience with Customer Relationship Management (CRM) Application, Master Data Management (MDM) Application and Data Warehouse Application.
• Application of various design validation tools - XRD, SEM, Hysitron, Instron with CAD/CAM and Solidworks in developing the artificial bones in sterile environment.
• Involved in validating computer system interface with laboratory equipments and sophisticated computerized laboratory equipments - Microplate Reader, GC, HPLC, Atomic Absorption spectrometer, LC/MS, Densitometers, Artel PCS, Face Imager, UV-Visible spectrometer, balance, titrators.
• Extensive experience in Change Management Control. A very proficiency in different workflows 0f Trackwise Application (Deviation, Defect and Incident management, Lab Events, CAPA).
• Excellent knowledge of Software Development Life Cycle (SDLC), Software Quality Assurance (SQA) and Software Validation Life Cycle (SVLC).
• Good working experience in Computer Systems Validations (CSV) in compliance with FDA and MHRA regulations like 21 CFR Part 11, Part 820, 203, 210, 211, and 58.
• Sound understanding of cGXP (cGMP, cGLP, cGCP) standards and GDP.
• Involved in writing Validation Protocols, Installation Qualification (IQ), Operation Qualification (OQ), Performance
• Proficient in conducting Unit, GUI, Functional, Integration, System, Performance and Regression testing on CRM and MDM applications.
• Experience in documenting Data Migration Plans, Periodic Review, GAP Analysis, Risk analysis, CAPAs and Remediation Process.
• Thorough understanding of cGMP, ICH Q8, Q9, Q10 requirements, and cleaning procedures including CIP, COP and SIP.
• Excellent problem solving skills, quick learner and capability to perform well under pressure. Possess excellent documentation skills with good structured writing.

TECHNICAL SKILLS

Software: MS-Office LabVIEW, Mathematica, MATLAB, Adobe Photoshop, CAD

Languages: C/C++, VB 6.0, HTML, PERL.

Operating System: Windows Server 2003/2008 R2, Windows 7/XP/Vista, Macintosh, UNIX

Computer System Validation: Trackwise, Veeva CRM, Empower Chromatography Data Software by Waters, LIMS, Eduneering- Compliance Wire, ARGUS

Regulations and Practices: 21 CFR Part 11/58/210/211/820 , GxP (cGMP, GCP, GLP, GDP) ISO 13485/14971/60812/9001

Business Tools: MS-Project 2003/2007/2010 , MS-Visio 2003/2007/2010 , MS Office 2003/2007/2010

Testing Tools: HP Quality Center, JIRA and QTP.

PROFESSIONAL EXPERIENCE

Confidential, Foster City, CA

PRODUCT Analyst/ IT QUALITY ANALYST

Responsibilities:

• Heading the Validation Team, implemented change management for different projects in ARGUS Drug Safety Projects and leading the change management board.
• Facilitating documenting requirements with Business in UK & Quality Department for the project S&C Metrics GS1.
• Drafting protocols, documents & other validation deliverables and routing for approvals.
• Performed risk assessment to address business and compliance risk.
• Implemented remediation strategy & Created SOPs, ITOPs and other Reports associated with the ARGUS.
• Performed technical reviews of thesystems,IQ, OQ and PQ scripts,Validationplan, and reports for each legacy system at high compliance risk.
• Ensured excellent communication, documentation and training.
• Supported technical staff with the change management tools and procedures for systematic, efficient processing of all change requests.
• Developed the process framework which was supported by our change management tool - GTrack, Trackwise.

Confidential, Foster City, CA

PRODUCT Analyst/ IT QUALITY ANALYST

Responsibilities:

• Critical participant within the administration/development of Salesforce.com platform for SLN 1.0 and SLN 2.0.
• Ability to support the vision of central point of access with a strong focus on user experience.
• Maintained user roles, security, profiles, workflow rules, etc.
• Maintained system metrics to track trends in usage and data integrity for all expense related data in GAS.
• Exceptional analytical, quantitative, and problem solving skills.
• Responsible for developing and updating the protocols - Configuration Specification (CS), Installation Qualification (IQ) and Traceability Matrix (TM), data management, dashboards, reports, and any other functional areas as required.
• Conducted analysis and documentation of existing business processes; recommend process improvements.
• Creating and managing complex workflow rules, data validations, and object
• Performed administrative functions in the Veeva CRM and AGS including activities such as maintaining user accounts, loading data, reports, resolving end-user technical issues, monitoring system performance and utilization.
• Documented, managed and implemented system change requests.
• Provided cross-functional support and assisted Sales management on projects as needed.
• Assisted with on boarding & training of new users.
• Provided support and coordination for Sales Operations team inquiries, ad-hoc requests and projects.
• Acted as the Lead IT Auditor on the company internal audits (periodic system validated state reviews, QMS periodic fitness for purpose reviews, etc.)
• Occasionally executed external audits of the company vendors, with the specific focus on IT controls.
• Acted as IT QA/QMS SME on specific GMP, GLP and GCP audits.
• Utilized GMP, ISO, or other quality frameworks in support of audit activities.
• Documented typical audit activities and content, such as plans and agendas, observations, proposed remediation, summary reports to the management, etc.
• Ability to identify, define and propose the quality framework improvements based on daily challenges.

Confidential, Morristown, NJ

Responsibilities:

• Remediation of the full lifecycle validation deliverables for enterprise wide Customer Relationship Management system.
• Developed spreadsheets to organize all documentation, deliverables and anomalies for a Salesforce Automation System.
• Coordinated with Business Analyst for Core Validation of Veeva CRM v16.0.0 to v20.0.0
• Developed validation deliverables including Installation Qualifications, Operational Qualifications, and Performance Qualifications in accordance with BRD for Sales Force Automation and Sample Accountability applications.
• Developed validation deliverables and SOPs for Veeva Systems for major releases from v18.0.0 and v20.0.0 and also actively participating with change control management for patch releases between v18.0.0 to v19.0.0 and v19.0.0 to v20.0.0.
• Assisted Product Manager for successful dry runs and setting workflows for successful completion of testing and executed IOQ protocols.
• Reported Test Incidents and Deviations and resolved the issue with the development team and maintained high quality despite aggressive timelines.
• Developed other documentation including Proposals, Validation Master Plans, Traceability Matrices, Validation Summary and Final Reports.
• Oversaw execution performed, assigned anomalies and deviations and provided status reports to management.
• Assisted clients with resolutions to system deviations and SOP development for internal and external projects
• Performed Quality Assurance review of executed test cases for clients.
• Acquired Veeva Vault Training and Hands on experience on Veeva Vault Workflows.
• Involved in auditing the application for 21 CFR Part 11 compliance related to Electronic Signatures and Electronic Records for a closed System.
• Reviewed, coordinated and maintained CSV Change Controls. Prepared Periodic Reports for outstanding Change Controls.
• Maintained Change control and qualification records and maintained paper archives, controlled documents, and electronic databases. Routed and archived documents for review and approvals.

Confidential

Change Control Analyst

Responsibilities:

• Led the GTS Change management process for all productions services.
• Established and maintained overall change management strategies
• Developed the Forward Schedule of Changes to be used by all GTS staff for scheduling
• Established the Change Advisory Board (CAB) process using Trackwise, presiding over all meetings, releasing meeting notes, coordinating E-CAB for non-business hour scenarios.
• Established change management KPIs to measure compliance and continual service improvement
• Served as the primary contact and coordinator for all change management activity for GTS services, applications and associated infrastructure
• Worked with delivery and operations managers to plan the deployment of changes into production
• Worked with service owners to develop standard rollback plans and impact analysis
• Regularly evaluated change management risks and developed and delivered solutions to address identified risks
• Quickly established and maintained relationships and diplomatically negotiate common approach
• Interacted with all levels of management to ensure business continuity
• Served as an alternate administrator for the change management system including administration of users, attributes, mapping, maintenance schedules, and system change requests using Trackwise.
• Developed management and team dashboards within the change management tooling to support transparency, awareness and KPI visibility

Confidential

Validation ANALYST

Responsibilities:

• Headed the team of Validation (Implementation Partners with Confidential Pharmaceuticals).
• Worked with Validation Manager in defining the boundaries of validation activities.
• Remediation of the full lifecycle validation deliverables for enterprise wide Customer Relationship Management system in accordance with GAMP.
• Documented and routed for review - Operation Qualifications (OQ) and User Acceptance Testing (UAT) test cases based on the User and Functional Requirement specifications (UFRS).
• Verified Process Mapping to outline initial validation plan and process control strategy.
• Drafted new SOP’s and trained all users on the systems, implications and impact of 21 CFR Part 11 compliant data systems on day-to-day functions.

Confidential, Northbrook, IL

VEEVA SYSTEM ADMIN / Business ANALYST

Responsibilities:

• Documented all aspects of the Computer Systems Development Life Cycle (SDLC) of iRep developed by VEEVA Systems and AGS by Cegedim in accordance with FDA regulations, particularly 21 CFR Part 11.
• Wrote following documentation for computer validation life cycle, in accordance with FDA regulations: Project Plan, Standard Operating Procedures, Design Specification, Unit Test Report, System Configuration Specification, User Acceptance Test, User and Functional Requirement Specification.
• Coordinated with System Analyst, Project Manager, Fusion Administrator, Finance SME, ETL Data Architecture SME and Business Analyst to setup the UAT and Post-Production environment.
• Ensured Data Migration Compliance from PSP (Polaris Speaker Portal Program) to Fusion - iRep and AGS(Cegedim).
• Validated login screens and access profiles in iRep developed by VEEVA Systems based on the user requirements for User Interface (UI) testing.
• Validated the different stages of the life cycle of iRep and maintained the quality of all project deliverables despite extremely aggressive timelines.
• Validated different modules of Aggregate Spend Solutions based on SUNSHINE ACT.
• Analyzed User and Functional Requirements (UFRS) to point out Gaps between critical functions of the system against predetermined system design.
• Conducted Gap Analysis for reporting purposes which helped in ascertaining the true milestones for the project and managed all the change control records.
• Working with System Development Manager and Fusion Administrator in defining the boundaries of activities in UAT.
• Created and reviewed User Acceptance Testing (UAT) test cases for different scenarios for real time execution of the Application in to improve customer-centricity based on the User and Functional Requirement specifications (UFRS).
• Wrote and executed test scripts based on the test plan and in accordance with Good Documentation Practices (GDP).
• Documented the Test Scripts and analyzed Test Scripts in detail to check if it has covered the functionalities.
• Conducted tests on technical features of iRep developed by VEEVA Systems and documented its usability.
• Conducted tests and completed all Site Integration Testing for Aggregate Spend Solutions.

Confidential

Validation Engineer

Responsibilities:

• Involved in the qualification of Instron 5544 with BlueHill software which is a force measuring instrument.
• Completed Vendor Training provided on BlueHill Software which is used to operate Instron 5544.
• Initiated the draft of Validation Plan detailing the validation deliverables and responsibilities of the team members.
• Co-ordinated with the Developer to complete the draft of System Configuration Specification.
• Completed the draft of Installation and Operational Qualification Protocol to test all the User Requirements and Configuration settings.
• Co-ordinated with Vendor for the execution of Vendor (IQ+OQ) protocols for Instron 5544. Routed the document for approval with Quality Assurance.
• Involved in the draft of Performance Qualification (PQ) protocol and proctored the execution of PQ by the user.
• Co-ordinated the draft, review, and approval of Operational SOP and Administration SOP for Instron 5544.