Regulatory Compliance:

• Stay updated on industry regulations and ensure that all documentation adheres to the relevant regulatory requirements.
• Collaborate with regulatory affairs teams to compile necessary documents for submissions to health authorities.

Document Control:

• Develop and maintain a comprehensive document control system to manage all organizational documents.
• Ensure proper version control and document numbering for easy retrieval and traceability.
• Implement document lifecycle management processes.

Quality Assurance:

• Work closely with the quality assurance team to ensure that documentation meets quality standards and supports compliance with Good Documentation Practices (GDP).
• Perform regular audits of documents to identify and rectify any discrepancies or non-compliance issues.

Standard Operating Procedures (SOPs):

• Assist in the development, review, and revision of SOPs to ensure they reflect current practices and comply with industry standards.
• Distribute approved SOPs to relevant departments and personnel, ensuring proper training and understanding.

Record Keeping:

• Maintain a centralized repository for all documentation, including batch records, validation protocols, and technical reports.
• Implement effective archiving systems for historical documents and records.

Communication:

• Collaborate with cross-functional teams to gather and organize information for documentation purposes.
• Communicate document-related changes and updates to relevant stakeholders.

Training:

• Provide training to staff on document control processes, SOPs, and other relevant documentation requirements.
• Ensure that all personnel are aware of and comply with document management procedures.

Continuous Improvement:

• Participate in continuous improvement initiatives to enhance document control processes and efficiency.
• Proactively identify areas for improvement and implement corrective actions.