QA specialist
Skills and Capabilities
* Strong interpersonal skills with the ability to work effectively in a global, cross functional environment
* Highly organised with the ability to manage multiple priorities simultaneously
* Strong time management and planning capability
* Effective written and verbal communication skills, including interaction with senior stakeholders
* Confident presentation skills
* Strong experience working with electronic systems and digital platforms
Experience
* Three to five years experience in a Quality or Quality Control role within a regulated life sciences environment
* Solid understanding of Quality Management Systems and Good Manufacturing Practice
* Hands on experience managing quality systems including deviations, change control and CAPA
* Experience preparing and reviewing batch related documentation to support batch disposition activities
* Experience using electronic Quality Management Systems
* Exposure to distribution or supply chain quality is an advantage but not essential
Role Overview
This position supports the ongoing operation, development and maintenance of the Quality Management System in a regulated manufacturing and supply environment. The role provides quality oversight to ensure compliant operations and supports batch disposition activities across internal and external partners.
Key Responsibilities
1. Preparation and review of manufacturing and testing documentation to support quality review and batch disposition
2. Providing quality oversight to manufacturing activities, including work performed by external partners
3. Management of quality systems including deviations, CAPA, change control and risk management to ensure regulatory compliance and appropriate escalation
4. Coordination and maintenance of controlled quality documentation
5. Supporting supplier qualification and ongoing supplier management activities
6. Monitoring quality performance indicators and preparation of quality metrics
7. Supporting the preparation of periodic quality reviews and related documentation
8. Supporting data preparation for routine management reviews
9. Participation in internal, supplier and self inspections as required
10. Management and coordination of customer complaint investigations and timely closure
11. Supporting the preparation, coordination and delivery of training activities
12. Operation and maintenance of electronic document management systems to ensure effective control of procedures and records
13. Supporting the ongoing maintenance and effectiveness of the Quality Management System in line with applicable regulatory requirements
14. Acting as a member of audit teams during regulatory or customer audits
15. Working closely with cross functional teams to meet timelines and deliver business objectives
16. Supporting distribution and active substance compliance activities where applicable
Additional Responsibilities
Additional duties may be assigned in line with business needs.