InnoMedica's team lives creative thinking and innovation combined with professional competence and patient proximity.
Become part of the young team and get involved in InnoMedica's goal of giving patients access to a new generation of nano-medicines. Apply now and actively contribute to the company's success. Unsolicited applications are also welcome. We look forward to receiving your application!
Scientist Quality Assurance Clinical Research
Place of work Bern
The focus of the Clinical Research team is the clinical development of InnoMedica's products, with the aim of being able to apply innovative drugs in clinical trials on patients and ultimately bring the drugs to market. As part of the team, you will be responsible for expanding and maintaining the quality management system. The focus of the position is on compliance with Good Clinical Practice (GCP) guidelines. This includes, among other topics, the supervision of quality aspects in the planning, execution, and protocoling of clinical trials in oncology and neurology. Furthermore, you will actively participate in interdisciplinary project teams or take over project planning and coordination yourself.
You are responsible for the maintenance of internal IT applications (e.g. ERP, laboratory software) and ensure their further development as well as the training of the users by supporting the approximately 50 employees and providing 1st and 2nd level support. Moreover, you take care of data and information management, including access control and data security. You are in charge of the validation of the IT system and its implementation in our quality system according to Good Manufacturing Practice (GMP). You also design concepts for the expansion and extension of existing IT systems, produce internal solutions and manage external procurement projects.
As part of the Quality Assurance (QA) team, you will be responsible for maintaining and expanding the pharmaceutical quality system. The focus is on compliance with GMP guidelines, which ensure the quality of the manufactured products. This includes, among other things, the supervision of quality aspects as well as the coordination of quality issues. The management of deviations, change requests as well as corrective actions and preventive actions are also part of your tasks as well as the review of batch documentation and product release preparations for preclinical and clinical studies. Furthermore, you will actively participate in interdisciplinary project teams or take over project planning and coordination yourself.
As part of the Production and Engineering team you will produce pharmaceutical products
for ongoing clinical trials. In this context, you contribute significantly to the development
of new GMP production processes with the aim of increasing production capacity. You will
be responsible for ensuring and documenting the high-quality standards according to cGMP guidelines. In interdepartmental projects, you will be involved in complex matters
regarding product scaling, product stability or process automation. Further, you will be in
charge of the evaluation, purchasing and maintenance of production equipment.
In this position, you are responsible for tasks in quality control of GMP drug products used for promising clinical trials and analytical development collaborating with R&D for pipeline products as well as optimizing and validating HPLC-based methods in the GMP-certified laboratory. Besides the lab work, your responsibilities in quality control include documentation of deviations, initiation of change requests, as well as equipment qualification and troubleshooting.
