Ankit Patel
Validation Engineer @Baxter International Inc.
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WORK HISTORY
Validation Engineer @Baxter International Inc.
Thetford, GB
Lead validation activities on specific projects including defining the validation requirements to ensure compliance with regulatory standards.•Manage multiple validation projects- Equipment validation, Process validation and CSV validation.•Develop processes and procedures to support and improve group practices and processes.•Preparation and execution of the IQ/OQ/PQ/FAT/SAT Protocols.•Performed Risk assessment, such as failure mode effect analysis (FMEA) and System impact assessment•Develop processes and procedures to support and improve group practices and processes•To provide technical support in Test Methods and processes during Technology / Process Development and Validation•Participate in the evaluation of failures and out-of-specification results impacting compliance with quality, safety, and other design/facility requirements.•Support on Global Project- Site Particulate Matter control strategy and Visual Inspection
EDUCATION
Trine University
Master's degree, Engineering/Industrial Management
Swami Sacchidanand Polytechnic college,Visnagar 650
Diploma, Mechanical Engineering
SILVER OAK COLLEGE OF ENGG., & TECH., AHMEDABAD 077
Bachelor's degree, Mechanical Engineering
University of Oklahoma
Master's degree, Mechanical Engineering
ABOUT ANKIT PATEL
Master of Industrial/Engineering Management with 8+ years of industry experience. Demonstrated history of working in the individual experience in the pharmaceutical industry. • Expertise in Validation, maintenance, calibration, project engineering and Computer system validation.• Expertise in preparation of SOP (Standard Operating Procedure). • Expertise in preparation and execution of the FAT/SAT/IQ/OQ/PQ, Control System Qualification, wrote and updated test plan, test cases, requirement traceability matrix, Change Control, Engineering Assessment, Calibration of the manufacturing and utility equipment. • In depth knowledge of the cGMP, ICH and ISO guidelines, different regulations of FDA and International standards like 21 CFR part 11, CFR 820, ISO 13485, 14971, 9001 and guidelines like GAMP5. And software such as, Minitab21, AutoCAD, Pro E, EMS, Vaisala software, ETQ, My Qumas, Caliber Qumas(Quality Assurance Management System) and Trackwise 8.• Experience with CAPA investigation, root cause analysis. Conducting and delivering analytical and engineering studies to support manufacturing equipment validation and mechanical trouble shooting.LEAN Tools- 5S | 6S | Control Plan | FMEA | Fishbone Diagram | Kaizen | Muda | Root Cause Analysis
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