qa specialist.

Here is an opportunity to be part of SVAR Life Science as our new QA Specialist for our service businesses covering ISO15189, GMP QC testing service and GLP/GCP. We are searching for you with deep competence and experience from the Med Tech industry and who can contribute with your expertise to maintain the right quality and meet set requirements. SVAR Life Science delivers the right answers at the right time to improve patient care and accelerate drug development and now we need to add competence to ensure we meet the increasing demands of the industry. 

SVAR has five different regulations to deal with and the main focus in this role is to handle QA related tasks regarding ISO 15189 and also GLP/GCP study reviews. This means that the role entails a great responsibility since you are the specialist regarding these standards and will have the main responsibility towards the diagnostic department. Common tasks for the role is to conduct study reviews, study reports and plans and to be responsible for complaints within diagnostics. You will act as QA approver for SOPs and other quality documents and quality processes. Other tasks is to participate in regular review of Laws and Regulations and to act as a support in supplier approval process. In addition, you will act as a representative at sponsor audits and lead inspections from regulatory authorities. Furthermore the role implies to train your colleagues within GLP and ISO 15189, when you are familiar with these regulations. ...