QA Sterility Officer

Job description

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

Profile

What skills do you bring to the table?

•         Scientific degree

•         Relevant experience in sterility assurance

•         Previous experience in QA in the pharmaceutical industry

•         Experience in GxP

•         Hands-on approach

•         Able to work on the shop floor with a coaching and mentoring style to impact individual experiences

•         Strong communication skills with all levels

•         Good oral and written communication skills (French & English)

What’s the offer you can’t refuse?

As an Akkodis Team Member, you will be:

•         Onboarded in your position via a buddy process

•         Supported in your career by your Business Manager

•         Actor of your training plan and your personal and professional development

•         Benefiting from a permanent contract

•         Benefiting from a competitive salary package including several extra-legal benefits

Do you any questions? You can contact me at marie.defruit@akkodis.com