Quality Assurance Associate (f/m/d)

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 a Phase I clinical trial for the treatment of burns and reconstructive surgeries. Clinical Phase II studies are underway in Europe and Switzerland.
For our Quality Assurance department in Schlieren, Switzerland, we are currently seeking an experienced
Quality Assurance Associate (f/m/d) 100%
The qualified candidate is a highly motivated, interactive individual that possesses the ability to work individually and collectively. He/she will demonstrate clear and professional verbal, written communication and reporting.
Your main duties
Ensuring the proactive, phase-appropriate management of a complete and independent Quality
Management System (QMS), as well as supporting and preparing for QA compliance readiness during inspections and audits
Ensuring compliance to codes, standards, regulations, and QMS requirements, including creation/revision of appropriate SOPs
Managing, preparing and maintaining key QA compliance systems (Deviations, CAPAs, Change
Control, Risk analysis, Audits)
Implementing and executing the activities related to the supplier management process as outlined in the SOPs (including supplier audits)
Maintaining QA activities in compliance with Swissmedic, EU, and FDA (if applicable) regulations across therapeutic areas
Participating in the collaboration and negotiations of Quality Agreements with third parties and material suppliers
Training matrix management
Preparation, reconciliation and archival of controlled copies for PROD and QC departments
Your background
You hold a M.Sc./PhD in a natural science field field (e.g., pharmacy, biology, tissue engineering, biotechnologies, and biomedicine) or a comparable education. Knowledge of medical device regulation is a plus. You gained 1+ years working experience in QA related role in pharmaceutical companies in a wide spectrum of QA activities.
Desired Skills and Experience
Must have work permit in Switzerland
At least 1 years of experience in QA related role in biopharmaceutical companies (ideally
ATMPs) in wide spectrum of QA activities, including active inspection experience Fluent in
English both oral and written, German is a plus
Attention to detail with excellent organizational and record keeping
Great sense of quality and responsibility
High level of accuracy and organizational skills
Demonstrate ability to work independently and efficient
Self-reliant in determining priorities
Excellent interpersonal skills and team-oriented attitude
Proficient in English, German is nice to have and any other languages are a considered a plus
Place of work
Grabenstrasse 11, 8952 Schlieren
We offer the unique chance to be part of a young and motivated project team with the vision to change the patients' quality of life. This interesting and challenging job will give you the opportunity to further develop your working skills in a biotech start-up environment and to get in touch with international partners and clinical trial centers. In summary you can expect:
A high pace start-up environment
Flexible working hours in arrangement with the team leader
Competitive benefit package
A young and dynamic team
26 days of holidays/year
Are you curious to find out more?
If you are interested in applying for this position, please send your complete application, which should include the following documents in English
One-page motivation letter
Curriculum vitae
Copies of degrees and references
by using the following link:
https://apply.refline.ch/517628/0787/index.html
For further information regarding the recruiting process, please contact our HR partner HC Solutions,
Annika Danielsson or Alessia Cesari.
HC Solutions AG Zollikerstrasse 153 8008 Zürich 044 915 12 12 www.hcsolutions.ch