Temporary Quality Specialist, Haarlem, Noord-Holland

The Company  
This client focuses on diseases where the need for new medicines is high and the cost high. This multinational is known as one of world’s biggest generic drug manufacturers. In the Netherlands, the core focus areas are neurology and pulmonology and the marketing of products for rheumatological conditions. 

Role Description
The Quality Specialist is responsible for ensuring consistent quality oversight of all products handled by Commercial Quality Netherlands, including medicinal products, food supplements, cosmetics, and medical devices. This position safeguards compliance with applicable European and Dutch regulations (EU GMP, MDR, commodities law, narcotics legislation), product registration files, and internal Teva procedures. 
The role supports the Commercial Quality (CQ) Head, Qualified Persons (QPs), and Responsible Persons (RPs) in daily operations and contributes actively to the continuous improvement  f processes within the quality management system. The position requires solid technical expertise, strong analytical capabilities, and hands?on experience with pharmaceutical quality systems. 

Responsibilities

• Quality System Deployment - developing, updating, and maintaining SOPs and work instructions in alignment with company standards and relevant national/international regulations, executing GMP and GDP compliance activities across the Commercial Quality department, initiating and lead process improvement initiatives, ensuring timely closure and follow?up of deviations, change controls, and CAPAs.
• Operational Quality Management System (QMS) Activities - evaluating GMP?related aspects such as risk analyses and validation requirements, and ensure ongoing compliance, registering and managing deviations; collaborating with manufacturing sites to initiate investigations and define corrective actions, coordinating with the pharmacovigilance team when required.
• Critical Quality Incidents – performing root cause analyses and impact assessments for quality incidents, preparing comprehensive risk assessments using relevant tools (e.g., FMEA), document incident?related information thoroughly and support decision?making and CAPA development.
• Project Management - leading and managing multiple quality?related projects and programs simultaneously. 

Requirements

• Higher Professional Education (HBO) level.
• Experience with GMP processes such as deviations management and OOS handling.
• 3–5 years of relevant experience.
• Background in pharmaceutical manufacturing or laboratory environments.
• Experience performing risk analyses and impact assessments.
• Understanding of pharmaceutical production processes, equipment, and laboratory operations.
• Strong knowledge of European and Dutch GMP regulations.
• Familiarity with product registration guidelines.
• Strong analytical skills and ability to work in a structured, systematic manner.
• Excellent writing skills.
• Ability to work independently, take initiative, and prioritize effectively.
• Comfortable following and executing planned work.
• Clear, concise communicator with strong stakeholder?management abilities.
• Professional fluency in Dutch and English (spoken and written).
• Collaborative, customer?focused, and able to build effective working relationships.
• Hands?on mindset with solid practical knowledge.
• Team?oriented and proactive approach. 

Other information
Apply to our vacancy for more information. Looking forward to getting in touch!    

57629