Sterisets Manufacturing S.A. is eager to welcome an ambitious Quality Assurance Pharmacist/Technician.
Sterisets Manufacturing S.A. is a medical device manufacturing company located in Penafiel, Porto. Sterisets Manufacturing S.A. is part of the STI Group, an organization operating in the medical industry supplying high-quality products for medical disposable market. From our locations in the Netherlands and Portugal, we serve our customers in >60 countries, from wholesale to hospitals.
What will you be doing?
As Quality Assurance Pharmacist/ Technician, you will collaborate in maintaining and improving the Quality Management System (QMS), preparing Technical Documentation for relevant authorities for CE marking and accreditation purposes. Monitoring, coordinate and execute laboratory tests will be key tasks of your responsibility.
- Executing, monitoring and coordinating Laboratory Tests (Internal and External);
- Analyze and validate results and reports from Laboratory Testing;
- Microbiology monitoring, environmental control and validation of cleanrooms;
- Planning and monitoring radiation sterilization tasks (according ISO 11137);
- Developing and maintaining product Technical Documentation (e.g., Clinical evaluation, Biocompatibility, etc.);
- Prepare/update standard operating procedures (SOPs) for regulatory compliance;
- Participate in the audits performed by Regulatory Authorities and on their follow-up;
- Contributing to Quality and Regulatory aspects of the business.
Who are we looking for?
- Higher education in Pharmacy, Biochemistry, Chemical Engineering or other relevant fields for laboratory testing;
- Professional experience in laboratories (preferably under ISO/IEC 17025);
- Experience in medical device industry (would be a plus);
- English language proficiency (speaking and writing);
- Good interpersonal skills and proactivity;
- Strong team player motivated by the success of the business.
What we offer:
- A challenging and varied full-time job
- A young and growing team to work in
- A rapid growing company with many challenges ahead in the next years
- A competitive salary
Application:
If you live within a 30km range of Penafiel, we look forward to your application.