QA Sterility Assurance Senior Expert

**Sterility Assurance Sr Expert**

Catalent Brussels’ site core activity is to produce Sterile Injectable Pharmaceutical products (prefilled syringes) using aseptic processing. Sterility Assurance is key to ensure compliant and excellent site operations reliably providing High Quality Products to our customers and patients. The role of the incumbent is to support implementation and maintenance of highly performant Sterility Assurance Practices, Procedures and System on Catalent Brussels site.

**The Role**
- Definition & 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
- Container Closure Integrity
- 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
- 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”
- Drive or Support implementation of new technologies related to Sterility Assurance
- Writing and approving periodical trending reports including CAPA decisions in collaboration with Business Stakeholders
- Leading, writing or supporting Sterility Assurance related Deviation Investigations (Impact Assessments & Root Cause Analysis) and Change Controls
- In collaboration with Business Stakeholders, define CAPA and Support implementation
- Help organizing the Site Sterility Assurance Review Board
- Drive/Support review and implementation of Regulations
- 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
- Continuous improvement of these Practices, Processes, Systems and Trainings
- Support the Environmental Monitoring Control activities (sampling, sample delivery to QC, reporting, excursion management)
- Support Audits & Inspections
- Networking with external industry associations
- Collaborate with and be able to coordinate the work of SA/EMC Officer
- Bachelor or Master Degree in Lifesciences or experience acquired through previous roles/missions
- Minimum 5 years experience in Quality Assurance and Sterile Quality Control within Pharmaceutical Manufacturing.
- Be an expert in Sterility
- Be fluent in French and English. Any other language is a plus
- Demonstrated Microbiological knowledge and experience
- Well-developed Logic & Common Sense
- Ability to influence others / convey ideas and opinions
- 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
- Good communicator (including presentation skills)
- Good training capabilities
- Promotor of digital solutions
- Excellent Technical Writing skills (Deviations and Reports)
- Effective Document Creation skills (SOPs, instructions and other standards)
- Ability to visualize performance using data / ability to interpret data
- People oriented with capabilities of creating a Great Place to Work
- Driven by purpose
- Customer/Business oriented with ability to protect boundaries (say “stop” if needed)
- Team player with ability to collaborate in multidisciplinary teams
- Problem solver (pro-actively detecting problems / finding & proposing solutions to these problems)
- Detail oriented
- Entrepreneur with Continuous Improvement attitude (Total Quality Management mentality)
- Innovative, creative & pragmatic
- Speaks-up in a constructive manner, even in front of (senior) leader
- Energetic, resourceful, dynamic, optimistic and resilient

**Position benefits**
- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry - a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Pension and Health Insurance from day one of employment
- Meal-Voucher, Eco-Vouchers
- Company Car
- 36 days’ holiday + bank holidays

**Catalent’s standard leadership competencies that are used to interview and for Performance & Developm