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Proclinical is seeking a dedicated individual for the role of Quality Assurance Architect. This is a temporary contract position of 7 months and is based in Bern, Switzerland.

Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.

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

Responsibilities:

Supports creation and implementation of the aseptic operator training program for the site in BernCreation and update of procedures and risk assessmentsensures adherence to global procedures and standardsCreation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)

Key Skills and Requirements:

Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.Experience in the pharmaceutical manufacturing industry, specifically aseptic processingDemonstrated experience in quality assurance and regulatory compliance with EU GMP AnnexGerman and English Business LevelEducation: Degree in Life Sciences

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.