QA Sterility Officer

AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.

As part of the development of the activities at one of our clients, we are looking for a QA Sterility Officer.

What are your responsibilities?

As QA Sterility Officer, you will provide support and expertise to the operations to ensure that the Manufacturing Performance Unit applies Sterility Assurance processes (a.e. Aseptic Practices, Environmental Monitoring, Cleaning and Sanitization, Sterilization, Media Fill) to confidently deliver products to patients with the highest sterility assurance level at an appropriate cost.

To be successful in this role, here are your main tasks:

•         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 these risks 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 QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks

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