Job Title: Quality Specialist
We are seeking a dedicated and experienced Quality Management Professional to join our team. This is an excellent opportunity for individuals who want to contribute to the maintenance of an Electronic Quality Management System.
About the Role:
This role involves supporting the achievement of Key Performance Indicators (KPI) targets, managing deviations and risk, and assisting with audits. You will work closely with the quality team to ensure that our systems meet GxP requirements and ISO 9001:2015 standards.
Responsibilities:
* Maintain the Electronic Quality Management System by ensuring it is up-to-date and compliant with regulatory requirements.
* Support the quality team in achieving KPI targets through data analysis and process improvements.
* Manage deviations and CAPAs, risk management, and change control processes to minimize risks and improve product quality.
* Assist as Deputy Responsible Person for Wholesale distribution authorisations and ensure compliance with regulatory requirements.
* Prepare for Regulatory and Client Audits by conducting thorough assessments and implementing corrective actions.
* Assist with ISO certification process for group entities by providing support and guidance.
* Integrate QMS into Business Units by collaborating with stakeholders and implementing best practices.
Requirements:
* Bachelor's degree in Life Sciences or a related field.
* Minimum 2 years of experience in Quality Assurance and Quality Management systems.
* Familiarity with GxP requirements and ISO 9001:2015 standards.
* Deputy RP experience is highly desirable.
* A full driver's license is required for travel purposes.