Role Overview
We are seeking a highly skilled Quality Assurance Specialist to join our team. This exciting opportunity involves contributing to the strengthening of our Quality Management System and company.
The Quality Assurance Specialist will work closely with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.
This role is ideal for someone who thrives in a start-up environment and can contribute to original ideas.
Key Responsibilities:
* Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvement
* Supporting the set up and shaping of our Quality Management Systems
* Preparing for our ISO - Certification and maintaining compliance within the ISO framework
* Writing and / or review of documentation which support GxP activities for accuracy, completeness, compliance and user friendliness, e.g., SOPs, instructions, validation documentation
* Leading, coordinating, or performing deviation investigations
* Management / Implementation of Corrective and Preventive Measures, Change Controls and Software Life Cycle Controls.
* Providing training to other parts of the business on the Quality Management Systems
* Participating in internal and external audits and implementing any resulting recommendations / actions
* Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary
* Consideration to General Data Protection Regulation (GDPR) in documentation
* To undertake any further duties, from time to time as may be reasonably required
Requirements:
* Understanding of relevant quality regulations, such as ISO and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
* At least 3-5 years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical/life science industries.
About You
We are looking for someone who is self-motivated, a multi-tasker, proven team player within cross functional teams. You should have strong work ethic and the ability to work independently.
You will be responsible for improving how things are done, as well as making sure they get done. If you enjoy critical thinking / evaluation of process problems skills and thrive in a start-up environment, this could be the perfect opportunity for you.
What We Offer
In return for your skills and experience, we offer a challenging and rewarding role that will give you the opportunity to make a real impact. You will be working in a dynamic and innovative environment where your contributions will be valued and recognized.