Quality Assurance Officer At Sagar Vitaceuticals Nigeria Limited
Sagar Vitaceuticals Nigeria Limited
full-time
Job Summary
The Quality Assurance Officer ensures that all manufacturing operations, production processes, cleanroom environments, and finished products at the Sagar manufacturing facility strictly comply with cGMP, WHO, NAFDAC, and international pharmaceutical standards.
This role focuses on quality systems management, batch record reviews, validation compliance, internal audits, and maintaining total quality governance across all operational stages.
Key Responsibilities
cGMP & Quality Systems Governance: Implement, monitor, and enforce Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and quality assurance protocols across manufacturing and utility operations.
Batch Document Review & Release: Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and analytical test results to ensure compliance before authorizing batch release.
In-Process Quality Assurance (IPQA): Conduct routine line clearances, operational inspections, and environmental monitoring checks in production, packaging, and cleanroom areas.
Deviations & CAPA Management: Investigate out-of-specification (OOS) results, product deviations, market complaints, and process non-conformances; design and follow up on Corrective and Preventive Actions (CAPA).
Validation & Qualification Oversight: Assist in validating manufacturing processes, analytical methods, cleaning protocols, and facility equipment/HVAC qualification (IQ/OQ/PQ).
Audit & Vendor Management: Participate in self-inspections (internal audits) and regulatory inspection readiness (e.g., NAFDAC, WHO); inspect incoming raw/packaging materials and assess vendor compliance.
Documentation & Training: Author, review, and archive SOPs, change controls, and quality reports; conduct cGMP and QA training sessions for facility personnel.
Qualifications & Requirements
Education: B.Sc. or B.Pharm in Pharmacy, Chemistry, Biochemistry, Industrial Chemistry, or a related Life Sciences discipline.
Experience: 2 - 5 years of hands-on Quality Assurance experience in a pharmaceutical manufacturing or consumer healthcare production facility.
Regulatory Knowledge: In-depth working knowledge of NAFDAC regulations, WHO cGMP guidelines, ISO quality systems, and pharmaceutical validation frameworks.
Core Competencies: High attention to detail, strong technical writing skills, analytical root-cause investigation skills, and audit readiness capability.