Sterility Assurance Senior Expert
Sterility Assurance Senior Expert
Catalent
Brussels, Belgium
The successful candidate will support implementation and maintenance of highly performant Sterility Assurance Practices, Procedures and Systems on Catalent Brussels site.
The Role
- Execution of the site’s Sterility Assurance Strategy and Practices in collaboration with other Business Stakeholders, including:
- Facility Design
- Media Fill Testing
- HEPA filter certification
- Smoke Testing
- Facility & Area Cleaning and Disinfection Program
- Gowning
- Aseptic Practices and techniques, including training of staff
- Environmental Monitoring (viable and non-viable)
- Contamination Control & Bioburden Containment
- Ensure the proper issuing of Sterility Assurance documentation to support the product release
- Supporting the definition and execution of the site’s Sterility Assurance Strategy and Practices in collaboration with the Sterility Assurance Team and with other Business Stakeholders
- A detailed understanding of the QMS/PQS with proven experience in Change Controls, Deviations, CAPAs, and Investigations
- Ensure Adequate Sterility Assurance related Deviation Investigation and Change Control Management
- Implementation, maintenance, continuous improvement and innovation of Practices, Processes, and Systems that are effective, practical, robust yet agile to ensure the Sterility Assurance Strategy is executed and leads to “being continuously in control”
- Writing and approving periodical trending reports including CAPA decisions in collaboration with Business Stakeholders
- Supporting Sterility Assurance related Deviation Investigations (Impact Assessments & Root Cause Analysis) and Change Controls in collaboration with Business Stakeholders, define CAPA and Support implementation
- Regularly GEMBA the Aseptic Practices and Environmental Monitoring Practices on the shop-floor to ensure adherence to implemented Standard Practices, Processes and Systems by all site personnel
The candidate
- Bachelor or Master Degree in Lifesciences or experience acquired through previous roles/missions
- Min 5 years experience in Quality Assurance and Sterile Quality Control within Pharmaceutical Manufacturing
- Demonstrated Microbiological knowledge and experience
- Fluent in English, French being a strong asset
- Capability to understand “product-patient-illness-treatment”-relation and ability to assess health risks and impacts as well as compliance and financial risks
- Ability to perform effective Impact Assessments and Root Cause Analysis
- Effective Document Creation skills (SOPs, instructions and other standards)
- Speaks-up in a constructive manner, even in front of (senior) leader
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