vor 6 Tagen

Quality Assurance Specialist (80-100%)

ETH Zürich

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Quality Assurance Specialist (80-100%)

 
CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin? has successfully completed Phase I in pediatric patients. Clinical Phase II studies are underway in Europe and Switzerland.
Quality Assurance Specialist (80-100%)
We are seeking to hire a quality assurance specialist, a new position in the area of quality operations that involves the implementation and maintenance of CUTISS' GMP quality management system (QMS). As a quality assurance specialist, you will be responsible for writing, reviewing and archiving QMS documentation (standard operating procedures and related materials), as well as providing support for the quality training program and promoting quality awareness. Acting as SME (subject matter expert) and as part of the core audit team, you will assist in the internal and external audit process. Responsibilities also include handling of deviations and assisting in the change management process. Support for GMP operations and manufacturing involves reviewing and approving validation and manufacturing documentation and batch production records. It also entails reviewing the quality of CUTISS research & development and approving product and process development documentation, including study protocols and reports. Moreover, you will provide support in the area of quality compliance, including assisting with quality documentation (writing and reviewing SOPs and other documents related to quality management). Finally, you will be responsible for supporting and overseeing the transfer of GMP technology from the Wyss Zurich to CUTISS (documentation and processes).
To be eligible for this position, you must hold the degree of bachelor or master of sciences and have a minimum of two years of work experience in GMP, and specifically in quality assurance. You must also have solid knowledge of GMP operations, ideally in biologics manufacturing, as well as experience in project management. In addition, you should ideally be familiar with pharmaceutical industry trends and practices and have a good working knowledge of EU and U.S. GMP regulations, as well as of quality systems in the pharmaceutical industry.

Candidates
should be excited about collaborating with a young and dynamic team in a fast-paced start-up environment. Excellent written communication and organizational skills, a detail orientation and the ability to keep accurate records are essential. This job also requires good interpersonal skills, fluency in English (both spoken and written) and a permit to work in Switzerland.
To hold this position, you must be able to work independently. You must be able to set priorities, goal oriented and capable of quality auditing. Good computer skills (e.g. Microsoft Office) are desirable. 
 
We offer flexible working hours, in arrangement with the department head, as well as a competitive benefit package and five weeks of vacation. The main workplace is located at Wagistrasse 27, 8952 Zurich-Schlieren, but some tasks may also take place at Weinbergstrasse 35, 8092 Zurich.
We look forward to receiving your online application including your CV and a motivational letter. Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered.
For further information about our company please visit our website: www.cutiss.swiss. Questions regarding the position should be directed to Mrs. Daniela Marino by email daniela.marino@cutiss.swiss or phone 076 230 80 46.