Overview
Are you passionate about quality and precision? Join our client in this Sterility Assurance position and help ensure top-tier standards every day.
Hobson Prior is seeking an accomplished and highly experienced Head of Sterility Assurance & Contamination Control to lead our comprehensive contamination control strategy within our sterile manufacturing operations. The successful candidate will be a recognized expert in GMP-regulated sterile environments, playing a critical role in ensuring the highest standards of product quality and regulatory compliance.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities
* Develop and oversee a comprehensive contamination control strategy for sterile manufacturing.
* Ensure compliance with global regulatory standards, including EU GMP Annex 1, FDA, EMA, and others.
* Lead efforts in cleanroom design, qualification, and control, including advanced facility upgrades.
* Address and resolve complex sterility issues, such as contamination events or test failures.
* Support regulatory remediation efforts and implement corrective actions when needed.
* Collaborate with contractors and manage external partnerships effectively.
Key Skills and Requirements
* Strong knowledge of sterile manufacturing processes, such as aseptic processing or terminal sterilization.
* Experience in designing and improving contamination control systems.
* Technical expertise in cleanroom operations, HVAC systems, and isolator technology.
* Ability to lead investigations and resolve sterility-related challenges.
* Professional proficiency in English; German language skills or willingness to learn are a plus.
For more information, please contact Jacob Tutt.
If you are interested in applying to this exciting opportunity, then please click Apply or to speak to one of our specialists visit the Contact Us page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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