Job Description
Your new company
A global pharmaceutical organisation committed to ensuring the highest standards of quality and compliance in the commercialisation of medicinal products. This company is dedicated to continuous improvement and regulatory excellence, working closely with health authorities, contract manufacturers, and internal stakeholders to uphold strict industry standards.
Your new role
As a Quality Assurance Specialist, you will be responsible for managing quality activities to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicinal products. Your key duties will include:
1. Overseeing the product release and compliance process, verifying documentation completeness, and ensuring adherence to quality standards.
2. Maintaining and enhancing Quality Systems, including Change Control, Deviations, Complaints, Product Quality Reviews (PQRs), Recalls, and Returns.
3. Acting as a liaison with Health Authorities, ensuring timely reporting of quality incidents and overseeing compliance with company policies.
4. Managing risk assessment and documentation, supporting technical knowledge-sharing within the organisation
5. Implementing and monitoring Corrective and Preventative Actions (CAPAs), tracking effectiveness, and preparing reports for senior leadership.
6. Engaging in continuous i...