GMP Change Coordinator | GMP Change Coordinator (all gender)
ALTEN Consulting Services GmbH
Job Summary
As a GMP Change Coordinator, you will play a critical role in the pharmaceutical and biotechnology manufacturing process by managing complex change requests. Your daily responsibilities include gathering relevant data for change applications, developing detailed implementation strategies, and coordinating with various specialist departments to ensure compliance. You will be responsible for entering these requests into the electronic Quality Management System (eQMS), specifically TrackWise, and defining the necessary review teams. This position is ideal for professionals who excel at cross-departmental coordination and have a deep understanding of Good Manufacturing Practice (GMP) standards. The role offers an attractive compensation package, flexible working hours with mobile work options, and a permanent contract within a stable, long-term engineering and IT consultancy environment. It is a unique opportunity to manage high-stakes changes in aseptic filling and biotechnology production environments.
Required Skills
Education
University degree in Engineering or a comparable qualification.
Experience
- Professional experience in the biotechnology or pharmaceutical industry
- Proven experience in GMP Change Management
- Hands-on experience using eQMS software, specifically TrackWise
- Professional experience in aseptic filling (highly preferred)
- Experience in coordinating cross-functional measures and implementation strategies
Languages
Additional
- Permanent full-time contract. Mobile work available by arrangement. Requires the ability to manage highly complex and detailed documentation within a regulated environment.
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