Document Control Administrator in भारत

Thermo Fisher Scientific seeks a Lead Document Control Administrator to oversee daily document management activities, maintain compliance and regulatory standards, and serve as the subject matter expert for document control processes and electronic systems. The role includes mentoring team members and collaborating across departments.

Responsibilities

• Coordinate daily document control activities and oversee document lifecycle management
• Maintain document accuracy, version control, audit trails, and regulatory compliance
• Provide technical guidance to end users and mentor team members on EDMS and procedures
• Support internal, customer, and regulatory audits; participate in change control and CAPA initiatives
• Generate performance reports and recommend process improvements for document control operations

Requirements

• Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or related field
• 3+ years of document control or quality systems experience in regulated industry
• Hands-on experience with Electronic Document Management Systems (EDMS)
• Knowledge of FDA 21 CFR Part 11 and 21 CFR Part 820 regulations
• Familiarity with ISO 9001 or ISO 13485 standards
• Proficiency with Microsoft Office Suite