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.
13 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.
