Are you a detail-oriented Qualified Person (QP) with a passion for ensuring the highest standards of medicinal product quality and compliance?
As a Qualified Person, you will oversee the batch release of medicinal products, ensuring compliance with regulatory standards and internal quality management systems. This role involves the release of sterile products.
Responsibilities
- Manage the batch release process for medicinal products, ensuring adherence to MHRA regulations.
- Review and approve manufacturing batch records, analytical data, and quality documentation.
- Investigate and resolve quality deviations, ensuring compliance with established protocols.
- Contribute to the management and improvement of the Quality Management System (QMS).
- Provide expert regulatory guidance and ensure compliance with evolving pharmaceutical standards.
- Participate in internal and external audits to maintain quality and operational excellence.
Ideal candidate
- Previous involvement as a releasing QP within sterile products
- Experience managing a Quality Management System (QMS).
- A robust background in pharmaceutical manufacturing and quality assurance.
- A qualification in a scientific discipline (e.g., pharmacy, chemistry, or biology).
- Completion of the educational requirements for QP certification
This role is fully site-based and does not offer remote working.