QA Senior Specialist for in vitro Diagnostics

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QA Senior Specialist for in vitro Diagnostics

About DIANA Biotechnologies

We are leading Czech biotechnology company with a great innovative potential. We focus on the development of products based on our cutting-edge research in the fields of molecular diagnostics and drug discovery. We have global ambitions and since our foundation in 2018 we already have achieved some of our goals. During COVID-19 pandemics, we were able to quickly develop one of the most innovative COVID-19 tests worldwide and we helped to increase the testing capacity of the whole country. As a result, we became the biggest Czech manufacturer of RT-PCR tests. Besides RT-PCR, we continue to focus on projects aiming to develop new molecular diagnostics, monoclonal antibodies and new drug candidates. This is possible thanks to our multidisciplinary team motivated to advance diagnostics and drug discovery.

We are a young and dynamic company being built by friendly and highly skilled colleagues, but at the same time we have already grown to a midsized company with around 100 employees and we have the ability to run long term and ambitious projects. If you join us, you will be part creation of a unique biotech company which is the first of its kind in the Czech Republic.

We are strengthening our Quality Assurance team and are looking for a QA senior specialist.

What will be your responsibilities?

  • You will work under supervision and guidance of our QA manager.
  • You will initiate, revise, and review controlled documentation including procedures and reports to be compliant with ISO 13485:2016 and IVD Regulation (EU) 2017/746 requirements.
  • You will provide constructive feedback to improve QMS documentation and procedures.
  • You will support management and employee training.
  • You will lead some of the QA processes (e.g., nonconformance and CAPA identification, investigation, and resolution).
  • You will participate in and provide compliance guidance for product development and manufacturing procedures.
  • You will participate in internal and external audits, including audits of Notified body.
  • You will ensure that all product documents are up to date and in accordance with current legislation.
  • You will be involved in discussions with the developers and manufacturers of kits likewise with the regulatory and sales and application support teams.

Who are we looking for?

  • Self-motivated professional with positive attitude and team spirit.
  • Finished master’s degree or equivalent education in biochemistry, molecular biology, pharmacology, chemistry or related fields.
  • Experience applying risk assessment principles according to ISO 14971 requirements.
  • Knowledge of basic of PCR methods is a plus or strong will to learn it.
  • Quality management system (ISO 13485:2016) experience in the medical device industry. IVD experience is highly preferred.
  • Experience with internal/external auditing is a plus.
  • Proficient in both written and spoken English: QMS and technical documentation is written mostly in English.
  • Detailed experience with writing the controlled documentation in accordance with ISO 13485:2016.
  • You should work in highly organized matter and with attention to details.

What do we offer?

  • Friendly and supportive environment
  • Diverse work in a dynamic and unique biotech company
  • Perspective of a long-term contract in a successful company
  • Participation in the production of unique diagnostic products
  • Possibility to gain detailed knowledge of regulation 2017/746 and ISO 13485
  • Opportunity to join the company at an early stage enabling your career development
  • Support of further education, courses, trainings, thorough onboarding process
  • Competitive salary and possibility of personal growth
  • Various benefits, including 5 weeks paid vacation, meal voucher allowance, sick days, pension contribution and regular company events
  • Full time employment contract

If you are interested, we are looking forward receiving your CV and a motivation letter.

When applying, please send us your motivation letter (tell us about your ambitions, project goals and skills you can contribute) and CV (incl. list of publications and at least two reference contacts).