You are an expert in design of aseptic process simulation? You have good QA skills (CAPA, deviation, validation protocols, etc.)? You have project management skills and you are a good communicator? This job is for you!
For one of our clients located in Brussels areas, we are looking for Qualification & Validation Specialist Media Fill. Our client is a pharmaceutical industry.
Qualification & Validation Specialist Media Fill
The Qualification & Validation Specialist reports to the Qualification & Validation Supervisor. The Qualification & Validation Specialist "Media fill" is an expert in the role.
The tasks are as follows
- Design the aseptic process simulation (Media fill, Sterile hold-time, Aseptic manipulation…)
- Supervise the annual program "Media fills"
- Review annually the number and type of aseptic manipulations to be simulated
- Ensure that all activities are performed according to the schedule
- Ensure that all activities are properly documented
- Write validation protocols and reports and other documentation related to the activities
- Investigate deviations and execute CAPAs
- Define and execute improvement projects and initiatives
- Participate in customer and authority audits
- Can be involved in other validation activities
- Master degree in Pharmacy/Biology/Bio-Engineering
- Experience in the pharmaceutical industry (sterile manufacturing and GMP's)
- Fluent in French and English
- Maturity in the role
- Excellent communication skills
- Team player
- Project management and leadership skills
- Stress resistance
Our clients offer an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits (insurance, lunch vouchers, etc.).