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QA System Expert
Pharmadiem
- Los Angeles, California, United States
- Los Angeles, California, United States
Über
Ensures Efficient Management and Execution of the Event & CAPA Process (GEMS). Ensures that events/CAPAs and associated investigations are appropriately and timely performed and documented. Ensure that reports are available. Supervise and support the activities related to Event & CAPA Process (GEMS – Trackwise 8) for the Site;
Effectiveness of Quality Systems deployment and execution is demonstrated through KPIs and management reviews are being conducted in line with Client Guidance. Define and manage the action plans to ensure KPI are satisfactory.
Participate to the Global Event Review Board.
Manage the MR of Quality Systems.
Manages the Quality Risk Management System.
Train employees on EVENT/CAPA system. Monitor the EVENT/CAPA system to ensure compliance to the Global procedures and Regulations and evaluate additional need for training/coaching of the users
Qualifications
Master degree in Chemistry/Biology/Quality/Agronomy/pharmaceutical sciences
Min 5 years’ experience in Quality or Manufacturing of biotech or pharmaceutical products.
Min 5 years’ experience in leading teams
Management and leadership skills
Sets clear Priorities, manages through KPIs
Excellent communication Skills with teams, peers, global partners
Good Organizational skills
Autonomous
Good English knowledge
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Sprachkenntnisse
- English
Hinweis für Nutzer
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