Quality Assurance Specialist
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* This role supports the maintenance of a Quality Management System (QMS) to ensure compliance with GxP requirements and ISO 9001:2015 standards.
* The Quality Assurance Specialist will work closely with the quality team to achieve KPI targets, support deviation and CAPA management, risk assessment, and change control.
* As Deputy Responsible Person for Wholesale Distribution Authorisations, the specialist will provide oversight and guidance to ensure regulatory compliance.
* The role involves preparing for regulatory and client audits, assisting in the certification process for group entities, and integrating QMS into business units.
* The Quality Assurance Specialist will also assist in data compilation and analysis related to Quality System performance, license maintenance, and business unit training on quality and compliance matters.
* Additionally, the specialist will be responsible for monthly reporting of metrics associated with the Quality Management System and ensuring timely completion of activities.
* Proactive highlighting of any issues around compliance is expected.
Requirements:
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* A degree in Life Sciences is required.
* Experience in Quality Assurance and Quality Management systems is necessary.
* Experienced professionals with knowledge of GxP requirements and ISO 9001:2015 standards are preferred.
* Previous experience working as a Deputy RP is advantageous.
* A full driver's licence is also required.