Job Overview

The Documentation Officer is responsible for managing, organising, and controlling all documentation processes within the pharmaceutical manufacturing company. This role ensures that all documents related to production, quality control, quality assurance, and regulatory compliance are properly created, maintained, and archived according to Good Manufacturing Practices (GMP) and regulatory requirements.

The Documentation Officer plays a critical role in ensuring that the company adheres to both internal quality standards and external regulatory guidelines, facilitating smooth audits and inspections.

Key Responsibilities

• Manage and maintain all company documents related to product manufacturing, quality control, and regulatory compliance.
• Ensure proper documentation procedures are followed for creating, revising, and approving Standard Operating Procedures (SOPs), batch records, protocols, and reports.
• Regularly update and distribute controlled documents to relevant departments and personnel.
• Review documentation for completeness, accuracy, and adherence to regulatory requirements.
• Ensure timely approval of all documentation by authorized personnel.
• Coordinate with cross-functional teams (Production, Quality Assurance, Regulatory Affairs) to obtain necessary information and approvals.
• Ensure that all documentation is compliant with industry regulations, including GMP, NAFDAC, and other local or international health authorities.
• Prepare and submit documents required for regulatory filings and audits, such as product dossiers, change control records, and deviation reports.
• Assist in the preparation of responses to regulatory authorities for any documentation-related queries.
• Maintain a comprehensive and organized filing system for all documentation, including physical and electronic records.
• Ensure that all records are stored securely and are easily accessible for audits and inspections.
• Oversee the retention and disposal of documentation in line with legal and regulatory requirements.
• Provide documentation support during internal and external audits, inspections, and regulatory assessments.
• Ensure timely retrieval and submission of documents during audits to demonstrate compliance with regulatory and quality standards.
• Address audit findings related to documentation processes and implement corrective actions where necessary.
• Train staff on proper documentation practices, including how to complete batch records, SOPs, and logs according to company procedures.
• Ensure all staff understand the importance of maintaining accurate records and are compliant with SOPs related to documentation.

Qualifications

Education

B.Sc./HND Physical sciences.

Experience

Experienced or inexperienced candidates with sound knowledge of key concepts will be considered.

Skills and Competencies

• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks and meet tight deadlines.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management software.
• Familiarity with regulatory documentation formats and templates.