Description
Our client, a pharmaceutical organisation, is looking for a Qualification/Validation Engineer to support their Injectable department.Location: Brussels area, Belgium
Duration: 6 months
Mission Description:
Within the Injectable department, our client is looking for a Q&V Support to :
• Write the qualification protocols
• Support the qualification & validation of autoclave, tanks, filter integrity tester etc.
• Ensure the good progress of qualification tests/trials
Mission responsibilities:
• Qualification of equipment (e.g. autoclaves) in correspondence with GMP and EU/US regulations
• Write protocols for qualification tests
• Perform qualification tests and manage deviations (CAPA)
• Support for production by updating/modifying the SOP’s and forms
• Interact with production operators to identify needs (is SOP/form clear? Is the SOP/form applied? If not, why?)
• Take action to ensure quality in the production zone
• Report to project leader
Specific professional/technical expertise and key skills required:
Language skills:
• French = mandatory
• English = nice to have
Experience in pharma sector (e.g. production, qualification/validation)
• team player
• ability to interact with different actors of different levels (managers, project leaders, production operators)
• ability to manage deadlines
• stress resistant
• ability to work in an environment with legal constraints
• Engineering background in production is nice to have