Quality Assurance Manager (LVP Infusion Plant) Ilorin

Erkang Pharmaceuticals is a multinational manufacturer of pharmaceutical products starting up in Ilorin, Kwara State Nigeria. Erkang Pharmaceutical is one of the largest manufacturers of Large Volume Parenterals (Infusion) and other products in the world. We are  recruiting to fill the position below:

 Job Title: Quality Assurance Manager (LVP Infusion Plant)

Location: Ilorin, Kwara

Employment Type: Full-time Core Objective

Ensure IV infusion production complies with GMP, prevent microbial, particulate and endotoxin contamination, and guarantee product release quality.

Core Job Responsibilities

Establish and maintain a Quality Management System (QMS) covering the full lifecycle of IV infusion products (from material procurement and production to market feedback). Organize and conduct full-element GMP self-inspections or mock audits, issue gap analysis reports and CAPA plans, and ensure a high on-time closure rate for non-conformities (e.g., ≥95%). Lead or support official audits (e.g., NAFDAC) and customer audits (e.g., large medical institutions, commercial partners) to ensure successful passing and avoid critical deficiencies.

Production Process & On-site Monitoring:

Conduct daily inspections and quality checkpoint assessments for IV infusion workshops (including compounding, bottle washing, filling and sealing, sterilization, light inspection, packaging, etc.), ensuring personnel operations and environmental monitoring meet sterility requirements. Review all changes affecting product quality (process, equipment, material changes) and conduct risk assessments. Supervise workshop quality checkpoints, develop special monitoring plans for appearance defects (visible particles, leakage), and reduce appearance defect rates of finished products.

Deviation, Change & Risk Management:

Organize investigation and review of all deviations, quality incidents, OOS and OOT results; identify root causes and implement effective CAPAs. Regularly identify, assess, control, and review quality risks in production, especially IV infusion-specific risks (sterilization F₀ value assurance, seal integrity, insoluble particles). Draft and review annual product quality reviews, perform trend analysis on quality data and monitoring data (environmental monitoring, water system monitoring).

Organize sampling, inspection review, and release review of raw materials, excipients, and packaging materials (PP ports, non-PVC multi-layer co-extrusion films, glass bottles), ensuring non-conforming materials and intermediates are not used. Collaborate with the Procurement Department to conduct on-site audits of key material suppliers and regularly evaluate their quality assurance capabilities.

Team Management & Cross-departmental Collaboration:

Manage, train and develop the QA team (on-site QA, system QA, document controllers, etc.), develop training plans to improve sterility assurance awareness. Coordinate with Production, Engineering, Logistics and other departments to handle quality-related matters.

Bachelor's Degree or above in Pharmacy, Pharmaceutical Preparation, Pharmaceutical Engineering, Biopharmacy, Chemistry, or related fields.

Industry experience: At least 10years of pharmaceutical production and quality management experience, with a background in sterile preparations, especially large-volume IV infusions. Management experience: At least 3 years of team management experience (QA Supervisor or Manager).

Regulations: Proficient in NAFDAC Drug Administration Law, latest GMP (especially the Annex: Sterile Medicinal Products); familiarity with EU GMP Annex 1 or FDA sterile processing guidelines is preferred. Sterility assurance: Deep understanding of IV infusion processes (terminal sterilization / aseptic processing), autoclave validation, HVAC systems, water systems, media fills. Tools: Skilled in risk management, deviation investigation tools (fishbone diagram, 5-Why), strong document writing and review skills. IT: Proficient in office software; experience with QMS, LIMS or other quality informatics systems is preferred.

Quality awareness: Strong principles, sharp quality risk identification ability. Communication: Excellent cross-departmental coordination and anti-pressure ability; able to make quick decisions for unexpected quality issues in continuous mass production. Decision-making: Good leadership, judgment, and decision-making ability; able to make science- and regulation-based decisions on material and product release.

31st October, 2026. How to Apply

Interested and qualified candidates should send their CV to: [Email hidden - Login to reveal] using the Job Title as the subject of the email.