Přehled

About DIANA Biotechnologies

We are the most successful czech biotechnology startup and we are just getting global. We started 2018 and since then we initiated successful research and development in human molecular diagnostics, original small molecule drug discovery and monoclonal antibodies. We already have product on the diagnostics market and we were the most important developer and manufacturer of COVID-19 PCR tests in the Czech Republic – we brought the most sensitive and patient friendly saliva tests on the market and tripled czech testing capacity, and lowered the cost of the tests at the same time. We continue our mission to provide own products in diverse biotech areas as well as developing our own original medical drugs.

Even though we are a young and flexible company, we already grew to 100 employees.  Our courage and healthy financial background give us the ability to run long term and ambitious projects with global impact. If you join us, you will be part of the creation of a unique biotech company which is the first of its kind in Central Europe.

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 five weeks paid vacation, sick days, MultiSport, 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: jobs@dianabiotech.com.