Core Objective

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

Core Job Responsibilities
Quality System Maintenance & Continuous Improvement:

Establish and maintain a Quality Management System (QMS) covering the full lifecycle of IV infusion products (from material procurement, 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).

Materials & Supplier Management:

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.

Qualifications
Education & Major:

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

Work Experience:

Industry experience: At least 5 years 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).

Professional Knowledge & Skills

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.

Core Competencies:

Quality awareness: Strong principle, 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.

Application Closing Date
3rd April, 2026.

How to Apply
Interested and qualified candidates should send their CV to: hr.erkangpharma@gmail.com using the Job Position as the subject of the mail.

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Quality Assurance Manager