Job Description

• 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. Futran Tech Solutions Pvt. Ltd.

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