Amit Jain
Director of Operations at Quality Agents, Llc
Based in Frederick, United States
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Seniority
Director
Department
Operations
Location
Frederick
Industry
Operations Consulting
Company size
40
Contact information
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a•••••••@qagents.org
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Background
About Amit Jain
Accomplished Validation and Project Management Expert with over 13 years of leadership experience in pharmaceutical, biopharmaceutical, and medical device industries. Expert in strategic quality oversight of facilities, equipment, and utilities, ensuring compliance with FDA, EMA, and ICH standards. • Proven track record of developing and harmonizing global quality standards, implementing control strategies, and leading commissioning, qualification, and validation (CQV) programs for large-scale manufacturing facilities. • Recognized for driving process improvements, leading cross-functional teams, and representing organizations in regulatory inspections and industry forums.• I possess a strong background in the Commissioning, Qualification, and Validation of Manufacturing Facilities, Laboratory Equipment, Process utilities, and Process equipment, as well as experience in developing Equipment and System specifications, Validation Master Plan, Validation test plans, Standard Operating Procedures, and other Quality Control functions.
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