Expert in Quality Management
il y a 1 mois
Pharmadiem, a leading management and engineering company for large projects, is seeking a seasoned Quality Assurance Systems Expert to support one of its clients in Belgium.
Key Responsibilities:
- Ensure the efficient management and execution of the Event & CAPA Process (GEMS) to guarantee timely and accurate documentation of events and associated investigations.
- Supervise and support the activities related to the Event & CAPA Process (GEMS – Trackwise 8) for the site, ensuring reports are available and up-to-date.
- Develop and implement action plans to improve KPIs and ensure compliance with client guidelines.
- Participate in the Global Event Review Board to ensure effective quality management.
- Manage the Master Record (MR) of Quality Systems and oversee the Quality Risk Management System.
- Train employees on the EVENT/CAPA system, monitoring compliance with global procedures and regulations, and identifying additional training needs.
Required Profile:
- Master's degree in Chemistry, Biology, Quality, Agronomy, or Pharmaceutical Sciences.
- Minimum 5 years of experience in Quality or Manufacturing of biotech or pharmaceutical products.
- Minimum 5 years of experience in leading teams.
- Strong management and leadership skills, with the ability to set clear priorities and manage through KPIs.
- Excellent communication skills with teams, peers, and global partners.
- Good organizational skills and autonomy.
- Proficiency in English.
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