Krunalkumar Patel Email & Phone Number

 Experienced in 21 CFR Part 210 & 211, 820, 58, 11 and depth knowledge of GLP, GCP, GMP, and GPvP guidelines. Assisted the Information Systems and department owner with the development of validation master plans and validation protocols consistent with good engineering practices and current Good Manufacturing Practices (cGMP). Experienced with Electronic Document Management Quality (EDMQ), Documentum e-room and Good Documentation Practices (GDP). Extensive experience in Functional, Black Box and Regression Testing in System and User Acceptance Testing. Broad knowledge and hands on experience, on all phases of SDLC Experience in Rational Unified Process, Agile ( Scrum and XP) methodologies Good experience in establishing project plan, milestones and metric dates and flow control of projects using Microsoft Project. Excellent working knowledge of Computer System Validation, Gap Analysis and Audit Trail.  Good knowledge in reviewing and modifying Validation Plan, Remediation Plan, Validation Report and SOP documentation.  Experienced in preparation and execution of technical and procedural remediation plans using Impact Analysis and Risk Analysis.  Participated in leading, development and execution of Qualification Protocols (IQ, OQ, and PQ) for various Analytical Instruments and lab informatics system.  Involved in interfacing SDMS and LIMS to various analytical systems. Experience in writing Standard Operating Procedures and validation policies. Involved in document management process and Project Management using Documentum eRoom.  Participated in periodic review process and documented Periodical Evaluation Report Developed and executed Test Plan, Test Script, Test case Specification and Test Release Reports for all phases of testing like Integration and System testing.  Experienced in internal audit, external audit and vendor audit.

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  Validation Analyst

  Otsuka Pharmaceutical Companies (U.S.)

  Nov 2013 - Present - San Francisco Bay Area

  IT Preliminary Assessment, Validation Assessment Report (VAR), Validation Plan (VP), User Requirement Specification (URS), Infrastructure Configuration Specification (ICS), System Setup and Installation Procedure (SSIP), Installation Qualification (IQ), Detailed Design Specification (DDS), System Test Plan & Report (STP/STR), User Acceptance Test Plan & Report (UATP/ UATR), Traceability Matrix (TM), Validation Summary Report and Release Management Plan & Report (RMP/RMR).

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  Stevens Institute Of Technology

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