QA specialist.

Job description
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.

Welcome to become part of a company that develops and grows continuously, that pushes the boundaries of innovation and that develops and launches new products that meet unmet needs!

Is this your next step? Then apply at www.randstad.se, no later than 2023-02-15. If you have any questions, please contact Senior Recruitment Consultant Emelie Lanner at emelie.lanner@randstad.se.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Responsibilities
Your most common tasks will be:


QA representative for ISO 15189.
 GLP/GCP study reviews.
 QA representative at sponsor audits and during inspections from regulatory authorities.
 QA contact for authorities (e.g. Swedac).
 QA support in daily work.


Qualifications
To thrive and to be successful in this role, you need to have the following experiences and knowledge: 


Education in for example biomedicine, biochemistry, chemical engineering, chemistry, pharmacist, nurse.
A few years of QA experience in a regulated industry.
 Competence within ISO 15189.
 Interest within GLP and GCP.
 Experience within inspections.
 Experience of complaints within diagnostics.
 Fluency in English, both spoken and written. 
 Good knowledge of Swedish.

Competence within GLP, GCP and GMP is an advantage. 
We want to get in touch with you who is experienced within QA and confident in your competence, since you will be given a great responsibility from start. That means you have to feel comfortable with driving and implementing the processes of i.eg. Change Requests, Deviations, CAPAs, Complaints and Validation documentation. 

As a person you are a self-starter and your way of working is defined by structure and setting plans, in order to meet your deadlines. To thrive in this role you have to be persistent and enjoy working in a dynamic environment. 

About the company
SVAR Life Science is a Swedish group of companies that invents, develops, and applies the best assay technology for drug development and clinical diagnostics with the goal to deliver new solutions tailored to customer requirements. We establish practical platforms for clinical routine testing, work to secure relevant competencies by sharing best practices and knowledge and our partnerships enable us to deliver flexible solutions depending on specific needs. 
We work to deliver the right answers at the right time to improve patient care and accelerate drug development. You can be sure of our answers: we’ve been working right across the clinical diagnostic value chain for more than 30 years.