Quality Assurance – Documentation Executive

Job Description

The QA Documentation Specialist will be responsible for managing and maintaining all
documentation related to quality assurance activities. This includes creating, revising, and
controlling documents, such as standard operating procedures (SOPs), quality manuals, test
reports, batch records, and validation documents, ensuring compliance with ISO and other
regulatory standard and practices.
Key Responsibility:
• Develop, manage, and maintain the documentation related to quality systems,
including SOPs, protocols, reports, and batch records.
• Perform periodic audits of quality documents to ensure they remain current and
compliant.
• Coordinate document control processes, including versioning, approvals, and
distribution.
• Assist in the preparation and organization of documentation for regulatory audits,
inspections, and internal reviews.
• Work closely with QA and cross-functional teams to support the development and
documentation of corrective and preventive actions (CAPA), non-conformance
reports, and other quality-related documentation.
• Ensure proper archiving and retrieval of quality-related documents in accordance
with retention schedules.
• Manage the change control process for QA documentation, ensuring that all changes
are properly documented and approved.
• Assist in the development and tracking of performance metrics related to QA
documentation.