Quality Assurance Director
19 hours ago
Quality Assurance Director
X4 Life Sciences is a growing generics pharmaceutical manufacturer seeking an experienced Quality Assurance Director to oversee the quality management system, ensuring continuous improvement and compliance with GMP regulations.
Your Key Responsibilities:- Review and refine the quality management system to identify areas for improvement and implement procedures to address deficiencies.
- Verify that all products manufactured, packed, and tested meet registered MA requirements, guaranteeing regulatory compliance.
- Analyze third-party audit reports for APIs and packaging materials to ensure they meet our high standards.
- Liaise with the Medicines Inspectorate to respond to MHRA inspections, maintain open communication, and ensure adherence to GMP and Manufacturing and Product Licenses.
- Maintain device family technical files and product-specific design dossiers, ensuring up-to-date regulatory compliance.
- Stay informed about evolving regulatory requirements and best practices in compliance control, applying this knowledge to drive process improvements.
- Approve specifications, sampling instructions, test methods, and QC procedures, including any amendments.
- Oversee supplier management, approving and monitoring raw materials and packaging components.
- Bachelor's or associate degree.
- A minimum of 5 years' experience in Quality Assurance at a manufacturing site.
- Previous leadership experience.
- Extensive Pharmaceutical Industry experience with hands-on experience in development/quality in a GxP environment.
The estimated salary for this role is £60,000 - £80,000 per annum, depending on experience and qualifications.
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