Quality Assurance Specialist

The Quality Assurance Specialist ensures that appropriate quality standards are consistently applied and maintained for pharmaceutical and nutrition products globally purchased by UNICEF Supply Division and Country Offices. The role involves compliance with Good Storage and Distribution Practices, quality inspection/testing, manufacturer approval, complaint handling, and supporting temperature-controlled shipments and GDP activities.

Responsibilities

• Use specialized commodity knowledge to ensure appropriate quality standards are consistently applied and maintained for pharmaceutical and/or nutrition products and food supplements globally purchased by UNICEF Supply Division and Country Offices.
• Ensure compliance with Good Storage and Distribution Practices (GSDP), ISO and other relevant international regulations, standards and guidelines, including integration of Quality Management Systems (QMS) requirements into work processes and functions.
• Responsible for selective quality inspection/testing of pharmaceutical and/or nutrition products on receipt in Copenhagen and at any location of manufacturing required, including the field, ensuring fitness for use and consistency between the item, the material specification and purchase order requirements.
• Under guidance of the supervisor, take part in approval of manufacturers of pharmaceutical and nutrition products and food supplements.
• Perform or arrange GMP/GDSP inspection of manufacturers and service providers where relevant.
• Manage handling of complaints and recalls of pharmaceutical and nutrition products under guidance from the supervisor.
• Arrange Pre-Delivery Inspections of Pharmaceutical and Nutrition products and food supplements to ensure compliance with specifications for the products.
• Work with relevant centers in Supply Division to implement temperature-controlled shipments of pharmaceuticals and other relevant products supplied to and from Supply Division as well as for direct shipment to the customer.
• Support implementation of GDP activities related to self-inspection and training.
• Perform any other duties as requested by the supervisor.
• Be willing and able to travel to duty stations, including emergency locations, as operational needs arise.

Requirements

• Master or equivalent (Advanced University Degree) in Pharmacy, Nutrition and Dietetics, Nutrition, Food Technology and any other related fields.
• At least 5 years of relevant work experience in Pharmaceutical, Nutrition, Quality Assurance, Quality Management, Supplier auditing, pharmaceutical quality, Food safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), inspection, procurement compliance and any other related fields.
• Fluency in English is required.
• Knowledge of another official UN language (Arabic, Chinese, French, Russian or Spanish) is desirable.
• UN collaboration, international collaboration, QMS auditor certification, GMP auditor certification are desirable.
• Relevant experience at country level, particularly in development, fragile settings and humanitarian contexts is desirable.

Skills

• Pharmaceutical Quality Assurance
• Nutrition Quality Management
• Supplier Audits
• Food Safety and Quality
• Good Manufacturing Practices
• Good Distribution Practices
• Quality Inspection
• Procurement Compliance
• Complaint Handling
• Temperature-Controlled Shipments
• Quality Management
• GMP Auditor Certification
• QMS Auditor Certification

Languages

English