Quality Assurance Role
As a Quality Assurance Specialist, you will contribute to the development of our company’s Quality Management System. This role requires an individual with expertise in GMP and GDP principles.
The ideal candidate should have strong knowledge of quality regulations, particularly ISO and GxP standards. You will work closely with our Development Operations Teams, QA Testers, and other stakeholders to deliver high-quality compliant products.
Key Responsibilities:
* Collaboration with Head of Quality Assurance to enhance internal compliance through continuous improvement.
* Supporting the set up and shaping of our Quality Management Systems.
* Preparing for and maintaining ISO certification within the framework.
* Writing and reviewing documentation supporting GxP activities.
* Leading deviation investigations, implementing Corrective and Preventive Measures, and Change Controls.
* Providing training on Quality Management Systems and participating in internal and external audits.
* Reviewing and evaluating customer complaints and considering GDPR requirements.
Requirements:
Essential:
* At least 3-5 years of experience in Quality Assurance within regulated industries, specifically pharmaceutical/life science.
Desired:
* Knowledge in GAMP, Good Automation Management Systems.
* Experience in working with quality compliance software and/or Computer Software Validation.
What We Offer:
This is an exciting opportunity to join a start-up environment where innovative ideas are valued. As a member of our team, you will have the autonomy to make an individual impact while working collaboratively with cross-functional teams.