Your role :
As a Quality Assurance Specialist II you will be responsible for leading and managing our supplier external audit program in the UK and supporting activities within the client services team such as hosting client audits and generating audit responses for our client audit program. The successful candidate will be responsible for leading and coordinating the UK supplier schedule, conducting supplier audits, processing new vendors and reassessments and coordinating and processing supplier complaints. Key duties include documenting and reporting on supplier audit inspections, reviewing and approving new suppliers, supplier questionnaires, supplier quality agreements, and managing supplier complaints to ensure regulatory compliance.
The successful candidate will also support the hosting of our customer audit program within the UK. Key duties will be hosting customer audits and coordinating audit activities (tours, document retrieval) with operations as well as coordinating audit responses and generating CAPAs related to customer audits. The role will also involve overseeing company Quality Management System (QMS) documentation, including Event (Deviations and Out of Specifications), CAPAs, Change Control, Effectiveness Checks and SOPs. Your role will include travel within Scotland, UK & Europe to conduct client & supplier audits.
Who you are:
* 2+ years’ experience in a quality role
* Hold a Degree or equivalent in a Biological Science or Quality Management.
* Previous experience working within a quality driven systems / or regulated environment (GMP and GLP).
* Excellent attention to detail is essential as well as logical in thought
* Strong Organisational skills
* Presentation & interpersonal communication skills
* Ability to set own work schedules to manage time and prioritise workload effectively.
* Ability to train & develop functional skills in others and support colleagues cross functionally on operational and transactional tasks.
#J-18808-Ljbffr