Aseptic Quality Specialist
4 days ago
Job Overview:
We are seeking an experienced Aseptic Quality Specialist to join our team at Grifols Worldwide Operations (GWWO). This role will involve performing aseptic sampling and environmental monitoring as part of the establishment of the Environmental Monitoring programme for aseptic manufacture and water systems.
Key Responsibilities:
- Reviewing and supporting sampling plans for water systems
- Routine sampling of Purified Water and Water for Injection
- Assisting and participating in qualification of clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required
- Liaising with Validation, Quality Control, Quality Manufacturing Assurance, Maintenance and the Operations team on execution of monitoring protocols
- Providing quality performance information as required
- Ensuring regular Quality interaction with other Departments
Requirements:
- Minimum of B.Sc Degree or equivalent third level education and at least 2 years' experience working in an aseptic pharmaceutical/ medical devices industry
- Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry
- Deep knowledge and understanding of the aseptic regulatory requirements
- Grade C/D environmental monitoring experience
- Possibility of Grade A/B environmental monitoring experience
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