QA Expert

Responsibilities

• As QA Expert you implement and maintain the local QMS
• You ensure quality training of personnel including assessment of training effectiveness
• You approve and review local procedures with quality impact
• You ensure effective management of product quality complaints (PQC) including routing the PQCs and samples to the manufacturing site
• You ensure complaint handling of physicians samples
• You coordinate local business and execute recalls
• You manage repackaging / re-stickering activities of doctor samples in coordination with regional and global quality organization
• You asses final disposition of returned, rejected, recalled or falsified products independent from commercial functions
• You manage and review Product Quality Reviews
• You ensure deviation management, overview, tracking and trending
• You manage CAPAs
• You ensure handling of temperature excursions during transport, warehousing and distribution
• You ensure change control procedures
• You ensure customers and suppliers have the appropriate HA authorization to manufacture, warehouse, distribute or purchase medicinal products

Requirements

• Master degree in pharmaceutical, chemical or biological sciences
• > 3 years of quality experience within pharmaceutical industry
• Knowledge of GDP
• In-depth knowledge of Quality Management System processes
• Experience in applications such as SAP, eQMS solutions and eLearning systems is a plus
• Excellent communication skills
• Languages: English & French