Validation Specialist
This role involves working with customers to ensure that their validation activities are carried out in compliance with customer requirements, company policies and procedures, and relevant international standards. The specialist will be responsible for establishing strong customer relations and providing exceptional customer service to meet or exceed qualification requirements throughout all stages of the validation.
The successful candidate will have a diploma or degree in life science or engineering and at least 1 year's industrial experience with knowledge of ISO13485 process validation and microbiological/chemical testing. In lieu of meeting the minimum educational requirement applicants with a minimum of 4 years' industrial experience preferably in EO sterilisation demonstrating strong technical skills comprehensive working knowledge of quality standards ISO11135 process validation microbiological/chemical testing associated with the EO sterilisation process may be considered.
In addition to excellent organizing analysing math skills required to determine organisational customer regulatory problems formulate corrective action plans attention detail ability work autonomously well others adapt changing duties responsibilities normal hearing range sufficient hear alarms bells horns.