Job Purpose
As a QMS Specialist you will maintain and develop the systems used within the MoonLake Development Quality Management System.
Key Accountabilities
Key Accountabilities
- Assist the QMS Manager in set-up, management and administration of the Quality Management. Systems (QMS), ensuring compliance with relevant regulatory standards.
- Manage the training tracking systems used within the Development Quality System, ensuring compliance with relevant regulatory standards.
- Assist the MoonLake Quality Team and QMS users in recording and tracking of Quality related events (quality issues, CAPA, effectiveness checks, changes, audits and audit schedules).
- Maintain and develop QMS tracking tools.
- Work with other members of the MoonLake Quality Team, ensuring the timely and logical location and storage of GxP documentation.
- As part of the Quality Team, ensure actions are communicated to client groups and progress tracked.
- As part of the Development Quality team, develop the QMS tools to ensure ongoing efficient support to client groups.
- Provide help and support to Development and Corporate staff using QMS tools e.g. Qualio.