Job Description:
As a Senior Quality Specialist, you will be responsible for executing quality risk management and site quality risk register processes.
* Execute quality risk management and site quality risk register processes
* Manage internal and external audits, inspections, preparation and execution
* Participate in site risk assessments to ensure effective governance and communication systems
* Implement site-driven improvement projects to meet business objectives
* Manage project timelines and achieve milestones through proactive planning and coordination
* Conduct quality reviews and approvals of SOPs, work instructions and forms to maintain regulatory compliance
* Perform gemba walk-downs and inspection readiness walk-downs to identify areas for process improvements
* Review and approve quality non-conformance records to minimize impact on business operations
The ideal candidate possesses a third-level degree in a science or pharmaceutical discipline and 3-5 years' experience in quality or compliance roles within the biological and/or pharmaceutical industry.