Job Overview
We are seeking an experienced Quality Assurance Specialist to contribute to strengthening our Quality Management System and organisation.
The ideal candidate will work hand-in-hand with Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.
-----------------------------------
About the Role
This is an exciting and innovative role with a small team of individuals who share a great culture. Our company values diversity, integrity and respect within the workplace.
Role Responsibilities:
1. Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvement
2. SUPPORTING THE SET UP AND SHAPING OF OUR QUALITY MANAGEMENT SYSTEMS
3. Preparing for our ISO 9001-2015 Certification and maintaining compliance within the ISO 9001 framework
4. Writing and/or review of documentation which support GxP activities for accuracy, completeness, compliance and user friendliness, e.g., SOPs, instructions, validation documentation
5. LEADING, COORDINATING, OR PERFORMING DEVIATION INVESTIGATIONS
6. Management/Implementation of Corrective and Preventive Measures, Change Controls and Software Life Cycle Controls.
7. Providing training to other parts of the business on the Quality Management Systems
8. Participating in internal and external audits and implementing any resulting recommendations/actions
9. Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary
10. Consideration to General Data Protection Regulation (GDPR) in documentation
11. To undertake any further duties, from time to time as may be reasonably required
12. Successful, timely completion of goals and objectives that strengthen the Organisation.
13. Progress reporting against deadlines
-----------------------------------
Requirements
We are looking for a highly skilled and motivated Quality Assurance Specialist with the following qualifications:
* Understanding of relevant quality regulations, such as ISO 9001 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.
-----------------------------------
What We Offer
We believe that diverse perspectives and backgrounds foster innovation and drive growth.