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Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.
Are you a Junior Sterility Assurance who's looking for a new professional project in a Pharmaceutical Industry ?
Feel free to contact me : firstname.lastname@example.org / +32(0)497/61.85.75
Provides support and expertise to the operations to ensure that the Manufacturing Performance Unit applies Sterility Assurance processses (aseptic practices, environmental monitoring, cleaning and sanitization, sterilization, media fill,...) to confidently deliver products to patients with the highest sterility level at an appropriate cost.
Support for the follow-up of procedures in the field
Write environmental reports
Reading of sample boxes
Drive and execute continuous improvement project or remediation plan related to sterility assurance, including change control management, SOP's review,...
Manage relationship with aseptic operations in the context of the tasks described
Identify potential quality and compliance risks and help to manage theses risk through the existing quality systems
Performs gap analysis, system effectiveness reviews and other management reviews, as required
Guarantees the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method, validation)
Ensures and supports the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required
Contributes to inter-MPU QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks
Experience in Sterility Assurance
Experience in QA in the Pharmaceutical Industry
Experience in GxP
PhD or Master in Sciences (microbiology, engineering, bio-engineering, pharmacy,...) or equivalent by experience
SAP - Excel - Word
Fluent in French
Good knowledge in English
Able to work on the shop floor with a coaching and mentoring style to impact individual experiences
Strong communication skills with all levels
Builds trusts and rapport with others
what do we offer?
We offer an attractive salary with extra-legal advantages :