Futran Tech Solutions Pvt. Ltd.
Document control Specialist
Futran Tech Solutions Pvt. Ltd., New Brunswick, New Jersey, us, 08933
• Executes the initiation, processing, routing, and archiving of cGMP documentation related to global specifications and methods.
• Manages and updates commercial specifications and methods (internal release, stability, regulatory and compendial), and supporting documents for all drug products, drug substances, intermediates, starting materials, excipients, reagents, and packaging components.
• Reviews and executes change actions for Global Testing Standard documents.
• Ensures alignment of department procedures with global and site policies and procedures.
QUALIFICATIONS AND EDUCATION REQUIREMENTS • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. • A minimum of 4 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred. • Strong teamwork, time management, organizational and communication skills, and the ability to follow written and verbal instructions are required. • Excellent computer skills and knowledge of MS Office and Document Management systems is required. • Detail-oriented with a quality mindset. • Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry. • Experience in providing guidance on compliance-related issues.
QUALIFICATIONS AND EDUCATION REQUIREMENTS • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. • A minimum of 4 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred. • Strong teamwork, time management, organizational and communication skills, and the ability to follow written and verbal instructions are required. • Excellent computer skills and knowledge of MS Office and Document Management systems is required. • Detail-oriented with a quality mindset. • Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry. • Experience in providing guidance on compliance-related issues.