QA Documentation Specialist

Job Description

Quality Assurance Specialist with strong expertise in GMP documentation and quality systems. This role blends traditional QA responsibilities with a focus on managing, reviewing, and controlling documentation to support compliance and operational excellence.

Key Responsibilities :

• Review, approve, and maintain GMP documentation including batch records, protocols, CAPAs, NOEs, and change controls.
• Ensure documentation aligns with regulatory requirements and internal quality standards.
• Support internal audits, inspections, and document readiness for regulatory agencies.
• Collaborate with cross-functional teams to implement document revisions and updates.
• Manage document control systems and ensure timely issuance and archiving of controlled documents.
• Assist in training personnel on documentation procedures and compliance practices.

Requirements