Documentation Officer at Sagar Vitaceuticals Nigeria Limited

Reports To: Factory Manager

Job Summary

• The Documentation Officer is responsible for creating, reviewing, controlling, maintaining, and archiving quality and regulatory documents in compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and company quality management systems.
• The role ensures that all controlled documents are accurate, up-to-date, and readily available to support pharmaceutical manufacturing, quality control, and regulatory compliance.

Key Responsibilities

• Prepare, review, issue, distribute, and control all quality system documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, reports, and forms.
• Maintain the document control system, ensuring only current approved versions are available for use.
• Assign document numbers, revision numbers, and effective dates in accordance with company procedures.
• Archive obsolete and superseded documents while ensuring traceability and retrieval when required.
• Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements.
• Coordinate document review and approval workflows with relevant departments.
• Maintain document logs, master lists, and revision histories.
• Support internal and external audits by retrieving and providing controlled documents.
• Monitor document expiry dates and coordinate timely reviews and updates.
• Ensure confidentiality and security of controlled documents and records.
• Assist in change control, deviation, CAPA, and risk management documentation.
• Train employees on document control procedures and documentation requirements.
• Support regulatory inspections by ensuring documentation is complete, accurate, and readily accessible.
• Maintain both electronic and hard-copy document filing systems.
• Perform periodic reconciliation of controlled copies distributed across departments.

Key Performance Indicators (KPIs)

• Timely issuance and revision of controlled documents.
• Zero critical documentation errors during audits.
• Compliance with document review schedules.
• Timely retrieval of archived documents.
• Audit readiness and successful inspection outcomes.
• Compliance with GDP and GMP documentation standards.
• Accuracy of document master lists and revision control.

Requirements
Qualifications:

• Bachelor's degree or Higher National Diploma (HND) in Pharmacy, Industrial Chemistry, Microbiology, Biochemistry, Chemistry, Biology, Pharmaceutical Technology, or a related science discipline.
• Additional certification in Quality Management Systems or GMP is an advantage.

Experience:

• 2–5 years of experience in document control or quality assurance within a pharmaceutical manufacturing environment.
• Experience with electronic document management systems (EDMS) is an added advantage.
• Knowledge of regulatory requirements from WHO GMP, PIC/S, FDA, EMA, or other relevant authorities is desirable.

Required Skills:

• Strong knowledge of GMP, GDP, and Quality Management Systems (QMS).
• Excellent document organization and record management skills.
• High attention to detail and accuracy.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Good analytical and problem-solving abilities.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong time management and organizational skills.
• Ability to handle confidential information with integrity.

Key Competencies:

• Accuracy and attention to detail
• Regulatory compliance awareness
• Integrity and confidentiality
• Planning and organization
• Teamwork and collaboration
• Communication skills
• Accountability
• Continuous improvement mindset

Working Conditions:

• Office-based role with frequent interaction with Production, Quality Control, Quality Assurance, Warehouse, Engineering, and Regulatory Affairs departments.
• May require occasional overtime during audits, inspections, or regulatory submissions.

Health, Safety, and Compliance:

• Adhere to all company Health, Safety, and Environment (HSE) policies.
• Comply with GMP, GDP, GLP, and all applicable regulatory guidelines.
• Participate in mandatory training and continuous professional development activities.

General Responsibilities:

• Perform any other duties assigned by the Quality Assurance Manager or senior management.
• Contribute to continuous improvement initiatives within the Quality Management System.
• Maintain professional conduct and uphold the company's quality culture at all times.