Job Title: Quality Specialist
We are seeking a highly skilled Quality Specialist to join our team. The successful candidate will be responsible for ensuring the highest standards of quality in our organization.
Key Responsibilities:
* Support the maintenance of our Electronic Quality Management System across business and quality teams to achieve Key Performance Indicator (KPI) targets.
* Manage deviations and Corrective Actions, Preventions (CAPAs), risk management, and change control.
* Act as Deputy Responsible Person for Wholesale distribution authorisations.
* Prepare for Regulatory and Client Audits.
* Assist with ISO certification processes for group entities.
* Integrate Quality Management Systems into Business Units.
* Compile and analyze data associated with the performance of Quality Systems (e.g., Management Reviews).
* Maintain Licenses including Manufacturing licenses and Wholesale Distribution Authorisation.
* Train business units on quality and compliance matters.
* Report metrics associated with Quality Management Systems monthly.
* Complete activities within required timelines.
* Highlight issues around compliance.
Requirements:
* Degree in Life Sciences.
* Experience in Quality Assurance and Quality Management systems.
* Knowledge of GxP requirements and ISO 9001:2015 requirements.
* Experience working as Deputy RP.
* Full driver's license.