Document Control Administrator

Overview

Document Control Administrator coordinating and overseeing daily document control activities to ensure controlled documentation is accurate, complete, and compliant.

What you'll do

• Coordinate daily document control activities for controlled documents.
• Manage controlled documents across creation, revision, approval, distribution, archival, and obsolescence.
• Maintain document accuracy, version control, and audit trails.
• Provide technical guidance and mentorship to end users.
• Partner with Quality, Regulatory, Manufacturing, Engineering, and Operations.
• Support internal, customer, and regulatory audits.
• Participate in change control, CAPA, and quality system initiatives.

What you'll need

• Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or related field.
• 3 years or more of document control or quality systems experience in a regulated industry.
• Experience with Electronic Document Management Systems (EDMS).
• Proficiency with Microsoft Office Suite.

Nice to have

• Advanced knowledge of document control principles and document lifecycle management.
• Experience with EDMS platforms such as MasterControl, Veeva, TrackWise Digital, SharePoint, or OpenText.
• Knowledge of FDA 21 CFR Part 11.
• Knowledge of FDA 21 CFR Parts 820 and ISO 9001 and/or ISO 13485, plus GMP/GDP, Change Control, CAPA, and Risk Management.

Details

• Location: Hyderabad, India.
• Work schedule: Mon-Fri (standard).