Documentation Officer

Key Responsibilities:

• Prepare, review, and format quality and regulatory documents including SOPs, batch manufacturing records (BMR), validation protocols/reports, regulatory dossiers, and audit reports.
• Maintain documentation control systems and ensure proper filing, archiving, and retrieval processes.
• Ensure compliance with Good Documentation Practices (GDP) and company policies.
• Coordinate document approvals and revisions through proper channels.
• Assist in document preparation for internal and external audits and inspections.
• Monitor document review cycles and ensure timely updates.
• Support cross-functional teams with document management and training.
• Maintain confidentiality and security of all documentation.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, or related field preferred.
• 1–3 years of experience in documentation control in pharmaceutical or regulated industry.
• Knowledge of GMP, regulatory requirements, and quality management systems.

Key Skills:

• Strong attention to detail and organizational skills.
• Excellent written and verbal communication.
• Proficiency in MS Office (Word, Excel, PowerPoint) and document management software.
• Ability to work under deadlines and manage multiple tasks.
• Understanding of GDP and regulatory document standards.