Job Description

Quality Documentation 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 • Bachelor’s degree completed. • Minimum 5 years of experience. • Strong background in GMP documentation and quality systems. • Proficiency in document control platforms and Microsoft Office tools. • Excellent attention to detail, organizational skills, and written communication. • Ability to work independently and in cross-functional environments.