Job Description
Head of Quality Opportunity at a Growing Generics Pharmaceutical Manufacturer
This is an exciting opportunity for a seasoned Quality professional with leadership experience in the pharmaceutical industry.
The successful candidate will be based in or around Hertfordshire and will oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause.
Your Key Responsibilities:
1. Quality Management System Oversight: Identify and address areas for improvement and ensure that procedures are fully implemented.
2. Product Verification: Ensure products are manufactured, packed, and tested to registered MA requirements.
3. Third-Party Audit Reports: Review reports for APIs and packaging materials and ensure compliance.
4. Complaints and Incidents: Accurately record and address complaints and adverse incidents in accordance with the company QMS.
5. MHRA Inspections: Host inspections, write response reports, and liaise with the Medicines Inspectorate to ensure GMP compliance.
6. Device Family Technical Files: Develop, manage, and maintain device family technical files and product specific design dossiers ensuring compliance with relevant regulations.
7. Regulatory Updates: Remain up to date with impending changes and developments regarding regulatory and compliance requirements.
8. Specifications and Procedures: Approve specifications, sampling instructions, test methods, and QC procedures.
9. Supplier Management: Approve and monitor suppliers of raw materials and packaging components.
Your Requirements:
* A bachelors or associate degree in a relevant field.
* A minimum of 5 years of experience in Quality Assurance at a manufacturing site.
* Previous experience in a leadership role.
* Extensive pharmaceutical industry experience with hands-on experience in development/quality in a GxP environment.
Estimated Salary: £80,000 - £110,000 per annum depending on experience.
This is a unique opportunity for a seasoned Quality professional to take on a challenging leadership role in a growing generics pharmaceutical manufacturer.