Quality Assurance/Quality Control
On behalf of our client Prostatype Genomics – a company on the threshold of an exciting journey within the prediction and treatment choice for prostate cancer patients – we are looking for a QA/QC.
Prostatype Genomics AB is the legal Manufacturer of in-vitro medical devices (RT-qPCR kit and a cloud-based software) for prognostic evaluation of prostate cancer. The company has an ISO 13485:2016 certified quality management system and is in the process of establishing compliance to IVDR.
The company that today is called Prostatype Genomics AB was founded in 2007 as a spin off from Cancer Center Karolinska (Karolinska Institutet, Stockholm, Sweden) in order to transfer the research results of the research group into clinical reality.
The Prostatype® Test System combines gene expression information with currently used clinical parameters (PSA, Gleason Score, and Tumor Stage) and calculates the so called P-score. The test is based on a unique database containing prostate cancer patients and provides decision support for patients and doctors when making a treatment decision.
Several studies have proven that Prostatype significantly improves the accuracy in predicting mortality compared to current clinical tools. The system is based on a gene expression test, which measures the expression of three carefully selected embryonic stem cell genes in prostate cancer core needle biopsies. In conjunction with currently used clinical parameters, the PrTS predicts overall survival in prostate cancer.
- Lead and drive the IVDR-implementation (in progress)
- Ensure ongoing compliance with ISO 13485:2016 and IVDR, and provide day to day support and leadership necessary to ensure product development
- Manage change control, document control, writing & reviewing SOPs
- QC test and release of product (RT-qPCR kit)
- Establishment and the continuous optimization and refinement of QC routines
- Coordinate with contract manufacturing organization and support quality agreements
- Follow-up and reporting of QC activities at Management Reviews
- As the Management representative, coordinate the reporting of the effectiveness of the quality management system at Management review meetings
- Lead and participate internal and external audits
- Promote quality awareness throughout the organization and provide Quality training
- Supplier management including supplier evaluation
- Be the primary contact person for Prostatype Genomics notified body, external auditors, and regulatory authorities
COMPETENCE REQUIREMENT AND ABILITIES
- M. Sc., or Ph. D. in a relevant Life Science subject
- At least two years of professional experience in QA relating to in vitro diagnostic medical devices
- At least one year of experience on maintaining QMS in an ISO 13485 regulated medical device industry setting
- Several years of experience in authoring Quality documents such as SOP:s, instructions for use, audit plans and study documents
- Preferably experience from Quality Control laboratory in the diagnostic industry
- Preferably experience on RT-qPCR technique and other relevant biomedical laboratory techniques
- Formal training in the EU IVD 98/79/EC and EU IVDR 2017/746
- Experience from working with e-QMS is preferable
If you want to know more, please contact Brice Group who is supporting Prostatype Genomics in this recruitment;
Anders Larsson, Partner, +46 73 203 46 91 or firstname.lastname@example.org or
Adina Lekberg Salamon, Senior Researcher, +46 739 744 334, email@example.com
We are meeting candidates continuously, so please make yourself heard as soon as possible.