For one of our client located in Wallonia, we are looking for several profiles to work in Sterility Assurance (Juniors and Experts).
Do you have a Bachelor Degree or a Master Degree in Engineering?
Do you have a first experience or are you an expert in Sterility Assurance/operational QA/Sterile Products Manufacturing within a pharmaceutical environment?
Do You have a strong knowledge of cGMP referential?
Then, you might be the specialist that we are looking for!
As a Sterility Assurance Professional, you are responsible - depending on your experience - of several tasks linked to sterility assurance.
You drive and execute continuous improvement project or remediation plan related to sterility assurance, including change control management, SOP’s review, …
You manage relationship with aseptic operations in the context of the tasks decribed
You identify potential quality and compliance risks and help to manage these risks through the existing quality systems
You perform gap analysis, system effectiveness reviews and other management reviews, as required
You guarantee the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)
You ensure and support the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required
You contribute to inter-MPU QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks
You have a Bachelor Degree or a Master Degree in Engineering.
You have a first experience or you are an expert in Sterility Assurance/Operational QA/Sterile Products Manufacturing within a pharmaceutical environment
You have a strong operational experience on the ground
You have a strong knowledge of cGMP referential
You have a first experience in using SAP
You have strong communication skills, an outgoing personality, synthetic skills.
Interested? Don’t hesitate to contact Amandine Planche – Talent Acquisition at Valesta
Phone: 010/68.53.30 – Amandine.email@example.com