Overview
The Lead Document Control Administrator coordinates and oversees daily document control activities to ensure the accuracy, integrity, and compliance of controlled documentation, acting as subject matter expert for document control processes and electronic document management systems (EDMS).
What you'll do
- Coordinate daily document control activities to ensure timely processing of controlled documents.
- Manage document creation, revision, approval, distribution, archival, and obsolescence.
- Serve as the primary resource for document control procedures and EDMS functionality.
- Maintain document accuracy, version control, and audit trails.
- Provide technical guidance and mentorship to End Users.
- Collaborate with Quality, Regulatory, Manufacturing, Engineering, and Operations.
- Monitor document metrics and recommend process improvements.
- Support internal, customer, and regulatory audits.
- Ensure compliance with company policies and applicable regulations.
- Participate in change control, CAPA, and quality system initiatives.
- Support EDMS upgrades, testing, validation, and user training.
- Generate reports and dashboards for document control performance.
- Provide day-to-day technical leadership and guidance.
- Mentor and train team members.
- Coordinate workload and priorities.
- Promote best practices and continuous improvement.
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).
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.
- Strong understanding of Quality Management Systems (QMS).
- Excellent organizational, communication, and problem-solving skills.
- Proficiency with Microsoft Office Suite.
- Knowledge of FDA 21 CFR Part 11, 21 CFR Parts 820, ISO 9001 and/or ISO 13485, GMP, GDP, Change Control, CAPA, and Risk Management.
Details
- Location: Hyderabad, India.
- Work schedule: Standard (Mon-Fri).
Read the full description and apply on the company’s own careers page.