Lipi Thakkar Email & Phone Number

-Multiple years of experience of Business Analysis, Project Management, Data Analysis and Solution Implementation in Gene Therapy, Biotechnology and Pharmaceutical industry.-Worked on projects related to multiple different applications/systems touching different business areas including Bioinformatics, Gene Therapy, R&D, Laboratory Information, Clinical Research & Regulatory Compliance/Submissions.-Hand on experience with gathering, analyzing, prioritizing, and managing business, user, functional and non-functional requirements.-Experience in designing UAT Plan, defining Test Cases, maintaining traceability matrix, developing, and maintaining Test Scripts, analyzing defects, and interacting with development team members in fixing the defects.-Proficient in Document Creation, Review & Approval process to ensure adherence with cGxP, GDP, GAMP, and other applicable regulations.-Specialist in authoring validation artifacts such as Change Request, Requirement Specifications, Quality Assurance Plan, Validation Strategy Document, Design/Configuration Specifications, Traceability Matrix (RTM), UAT, Qualification Protocols (IQ, OQ, PQ), Validation Summary Report, Standard Operating Procedures (SOP), User Guide and Training Manual.-Experience in performing CAPA activities, Root cause analysis, Non-conformance Investigation, Gap Analysis, DFMEA, PFMEA, and Risk Management activities.-Solid understanding of FDA regulations, 21 CFR part 11, Annex 11, 21 CFR 820, USP 1058, cGXP (GMP, GLP, GCP), ISPE, GAMP 5, MHRA, ISO9001, and ICH E6.-Applied industry best practices for stakeholder management, meeting facilitation, project management, project scope definition and risk & issue identification.-Experienced in creating Standard Operating Procedures (SOPs), Work Instructions (WI), Trainings and Technical Documents

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  Gxp Technical Business Analyst

  White Collar Technologies, Inc

  Jan 2016 - Present - United States

  Supporting end to end SDLC activities and its execution for various IT systems used in QC, Clinical, Manufacturing and R&D for clients of White Collar Technologies.

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  Nv Patel College Of Pure And Applied Science

  Bioinformatics