Jayesh Chaudhari Email & Phone Number

San Carlos, California, Us

1. Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross-functional groups such as Manufacturing, Quality Control, IT, Engineering,and Validation.2. Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle, and improvements.3. Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA-A (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL).4. Creating and maintaining company documentation, such as quality manuals and procedures.5. Apply good manufacturing practices and observe that they are being adhered to.6. Represent Quality on cross-functional teams to complete projects, address quality issues, and implement quality system improvements.7. Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.

Lawrence Township, Nj, Us

• Prepare & Execute Test Documentation for GMP Computerized Systems & troubleshoot issues during test execution.• Design, author, and carry out Computerized System Validation per the mandated requirements under 21 CFR Part 11, ICH standards, EMA, FDA (GxP) regulations, and GAMP methodologies.• Coordinate with a multi-disciplinary validation to support the validation of automated equipment and control systems.• Create and modify validation documentation such as User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, and CSV protocols.• Review and approve Requirement Specification documents to ensure they meet project requirements.• Review System Implementation Plans and System Implementation Summary Reports for accuracy and completeness.• Pre-approve ST/UAT Test Scripts in ALM to verify they align with project objectives and conduct Post Execution Reviews and obtain post-approvals in ALM & ensure successful implementation.• Create and update Regulatory Risk Assessment (RRA) documents, obtain necessary approvals, and provide approvals for gR Implementations as needed.• Review Retirement Plans and Retirement Summary reports to ensure orderly system decommissioning.• Ensure timely delivery of project deliverables such as Requirement Document, Validation/Test Plan, Requirement Traceability Matrix, Change Requests, Impact Assessment document, and Test/Validation Summary Report.

Rahway, New Jersey, Us

1. Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems.2. Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents.3. Translate technical information and requirements into qualification/validation test design.4. Contribute to the overall growth of Merck’s compliance business. 5. Actively involved in integrating various Commercial Off-the-Shelf (COTS) software systems. 6. Validation (CSV) lifecycle in accordance with FDA regulation including 21 CFR Part 11 requirements.7. Focus on problem identification and help in processing of CAPA (corrective and Preventive Action) reports and Change Control to ensure compliance with established procedures.8. Develop IQ/OQ/PQ test scripts and execute the protocols to validate the laboratory facilities to the latest GLP regulations.9. Responsible for ensuring the compliance of GLP,GMP and FDA Regulations.10. Document Deviation reports when the test criteria didn’t meet the acceptance criteria and from the Documentation point of view.11. Handle CAPA tasks including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.

New Brunswick, Nj, Us

1.Responsible for revising information from existing process definition documentation, create new SOP and Work Instruction document drafts.2. Perform technical writing research, and editing functions to prepare protocols, reports, manuals, presentation, guidelines, and other written materials. 3.Update and Review Validation documents like URS, Risk Assessment, Compliance Plan, Compliance Analysis, Requirements Traceability Matrix, Validation Protocols (IQ/OQ/PQ), Validation Summary Report, etc.,4. Create change notices to obsolete procedures and update database spreadsheets.5.Route new and/or updated documents into Docspace &TruVault (EDMS) for the review and approval process.6.Accountable for the ongoing FDA Quality Systems and activities for addressing quality standards utilizing: 21 CFR, Part 11,820 Parts 210 & 211 (cGMP), ISO 9001, ISO13485, ISO14971.7.Responsible for risk management and the creation of risk management plans, Failure Mode Effect Analysis (FMEA) and Corrective Action & Preventive Action (CAPA) documents. 8. Carry out an investigation of Root Cause Analysis for customer, Vendor complaints and internal rejections.

Executive Mba, Organizational Leadership & Project Management

Master'S Degree, Mechanical & Aerospace Engineering