Description

You will manage the lifecycle of quality assurance documentation and ensure regulatory compliance through precise record keeping.

Responsibilities

• Implement Change Requests (CR), Document Change Orders (DCOs), and other controlled documents accurately and on schedule.
• Maintain documentation manuals, templates, and GXP documentation to ensure all information remains current.
• Perform data entry, scanning, and archiving of documents while verifying work for conformance to established formats.
• Support internal and regulatory audits, inspections, and the periodic document review process.
• Provide user training for electronic systems and monitor monthly document control metrics.

Required Skills

• 5+ years of experience in QA documentation or document control.
• Proficiency in managing Change Requests (CR).
• Experience handling Document Change Orders (DCOs).
• Knowledge of GXP documentation standards and maintenance.
• Ability to perform detailed format and template conformance checks.
• Experience supporting regulatory audits and inspections.
• Competency in word processing and database entry.
• Any Graduate degree.

Key Skills

Education

Any Graduate