We are focusing on the development and production of PCR based human molecular diagnostics. We are looking for an enthusiastic colleague for the position of Senior Quality Assurance Specialist. You will work within QA/RA department, and you will lead or contribute to system and process improvement projects to ensure regulatory compliance for our innovative products in human molecular diagnostics.
What will be your responsibilities?
- Work under supervision and guidance of our QA manager.
- Initiate, review and revise controlled documentation including procedures and reports to be compliant with ISO 13485:2016 and IVD Regulation (EU) 2017/746 requirements.
- Provide constructive feedback to improve QMS documentation and procedures.
- Support management and employee training and manage training programs.
- Manage and/or execute CAPA, change requests and nonconformances.
- Participate in internal and external audits, including Notified Body audits.
- Provide compliance guidance on product development and manufacturing procedures.
- Ensure that all product documents are up-to-date and in accordance with current legislation.
- Participate in internal discussions with other teams.
Who are we looking for?
- You have a master's degree in biology, chemistry, medicine or a related field.
- You are able to work independently under ISO 13485, ISO 14971 and IVDR.
- You have experience in writing controlled documentation in the in-vitro diagnostic or medical device field (either from a development or manufacturing company, or from a consultancy).
- You are proficient in both written and spoken English.
- revious experience in quality auditing, both internal and external, is highly desirable.
- If you have knowledge of basic PCR methods or immunoassays, it is an advantage.
- You can work independently and as part of a team and have excellent time management, organisational and communication skills.
What do we offer?
- A friendly work team motivated by improving the lives of people through development of new drugs and diagnostics. You will be in contact with people across the company.
- Competitive salary reflecting your seniority level and your contributions.
- A stimulating and diverse job in a dynamic and unique biotech company with global ambitions.
- Active sharing of know-how within the company, development of knowledge and skills.
- Various employee benefits: 5 weeks paid vacation, meal voucher allowance, sick days, pension contribution, Multisport card, refreshments and excellent coffee at the workplace, and more!
- Full-time employment contract with place of work in Zlatníky-Hodkovice, parking on site.
About us
We are successful biotechnology startup with unique products and global ambitions. Our main research and business areas are human molecular diagnostics, life sciences, monoclonal antibodies and small molecule drug discovery. In all these four areas we are bringing unique products to the global market.
We are both research oriented and also successful in business. Our products are based on internal cutting-edge multidisciplinary research. Furthermore, we are actively seeking market opportunities, and we have therefore been the most important developer and manufacturer of COVID-19 PCR diagnostics in the Czech Republic. We are continuing our mission of providing our own products in diverse biotechnological areas.
Even though we started the company just in 2018, we have already grown to over 100 employees. From the beginning, we aim to run long-term, ambitious projects with a global impact. If you join us, you will be a part of the creation of a unique biotechnology company which is the first of its kind in Central Europe.
If you are interested, we look forward to receiving your cover letter (describe your experience, ambitions and skills you can contribute, and explain why you want to work for us in this particular position) and CV.
