QA Manager (Sterility Assurance)

Hobson Prior is seeking a QA Manager (Sterility Assurance) for a contract role. The successful candidate will play a crucial role in the implementation of the aseptic Isolator Filling Line. This role requires a strong technical understanding of sterility assurance of aseptic cleanroom facilities, their processes, equipment, and personnel.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• For this role you will, support the implementation of the aseptic Isolator Filling Line.
• Create and update procedures, risk assessments, and concepts.
• Ensure adherence to global procedures and standards.
• Assist in the creation of the aseptic process validation concept for a new Isolator Filling Line.
• Support the creation of aseptic process validation reports, protocols, and procedures.

Requirements

• Proficiency in German and English.
• Strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes, and equipment.
• Familiarity with design, use, life cycle management, and cGMP compliance.
• Experience in the pharmaceutical manufacturing industry, particularly in sterility assurance of aseptic processing.
• Extensive experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors, and gowning.
• Experience in quality assurance and regulatory compliance with GxP, FDA, EU, and other regulatory agency guidelines.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select 'Contact me' at the top of this 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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