We are seeking an experienced Quality Assurance Specialist to strengthen our Quality Management System. The ideal candidate will work closely with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.
Responsibilities:
* Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance through continuous improvement.
* Supporting the setup and shaping of our Quality Management Systems.
* Preparing for ISO 9001-2015 Certification and maintaining compliance within the ISO 9001 framework.
* Writing and/or reviewing documentation which support GxP activities for accuracy, completeness, compliance, and user-friendliness.
* 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.
The ideal candidate should have strong analytical skills, excellent communication skills, and the ability to work independently.
Requirements:
* Understanding of relevant quality regulations, such as ISO 9001 and GxP.
* At least 3-5 years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical/life science industries.