Documentation Executive at Sagar Vitaceuticals Nigeria Limited

Job Summary

• The Documentation Executive is responsible for creating, reviewing, controlling, maintaining, and archiving all pharmaceutical documents in compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
• The role ensures that documentation is accurate, up-to-date, and readily available to support manufacturing, quality assurance, audits, and regulatory inspections.

Key Responsibilities

• Prepare, review, issue, revise, and archive controlled documents such as Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, reports, forms, and logbooks.
• Maintain the document control system to ensure all documents are properly numbered, approved, distributed, and withdrawn when obsolete.
• Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and company quality policies.
• Coordinate document review and approval workflows with cross-functional departments.
• Maintain master copies of controlled documents and ensure only current versions are available for use.
• Monitor document revision schedules and initiate timely updates.
• Support internal, customer, and regulatory audits by providing required documentation.
• Archive completed documents according to company retention policies and regulatory requirements.
• Maintain confidentiality and security of controlled documents.
• Track document issuance, retrieval, and destruction records.
• Assist in change control, deviation, CAPA (Corrective and Preventive Actions), and risk management documentation.
• Ensure documentation complies with regulatory requirements from authorities such as FDA, EMA, WHO, and local regulatory agencies where applicable.
• Train employees on document control procedures and Good Documentation Practices.
• Support electronic document management systems (EDMS) where implemented.
• Coordinate with Quality Assurance, Production, Quality Control, Regulatory Affairs, Engineering, and Warehouse departments to ensure documentation accuracy and completeness.

Key Performance Indicators (KPIs)

• Timely preparation and issuance of controlled documents.
• Accuracy and completeness of documentation.
• Compliance with GMP and GDP requirements.
• Number of documentation errors or deviations.
• Timely closure of document revisions.
• Audit readiness and successful inspection outcomes.
• Document retrieval and archival efficiency.

Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biochemistry, Life Sciences, or a related discipline.
• Additional certification in Quality Management, GMP, or Documentation Control is an advantage.

Experience:

• 2–5 years of experience in pharmaceutical documentation, quality assurance, regulatory affairs, or manufacturing documentation.
• Experience working in a GMP-compliant pharmaceutical environment is preferred.
• Familiarity with electronic document management systems (EDMS) is desirable.

Required Skills:

• Strong knowledge of GMP, GDP, GLP, and pharmaceutical quality systems.
• Excellent document preparation, proofreading, and organizational skills.
• High attention to detail and accuracy.
• Strong communication and interpersonal skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Ability to manage multiple priorities and meet deadlines.
• Analytical and problem-solving skills.
• Ability to maintain confidentiality and data integrity.

Key Competencies:

• Attention to detail
• Organizational and time management skills
• Regulatory compliance awareness
• Teamwork and collaboration
• Integrity and accountability
• Planning and coordination
• Documentation accuracy
• Continuous improvement mindset

Working Conditions:

• Office-based with regular interaction with manufacturing, quality control, and warehouse areas.
• May require participation in audits, inspections, and validation activities.
• Must comply with company health, safety, and pharmaceutical GMP requirements.

Career Progression:

• Senior Documentation Executive
• Documentation Supervisor
• Quality Assurance Officer
• Quality Assurance Executive
• Documentation Manager
• Quality Assurance Manager