Job Summary
As a Pharmaceutical Quality Manager, you will be responsible for overseeing the operation of an effective quality management system and ensuring that all regulatory obligations are met. This role involves collaboration with senior management and other teams to maintain high standards of quality and compliance.
Key Responsibilities
* Manage communications with regulatory bodies and represent the company during inspections.
* Support internal audits and prepare responses to regulatory inquiries.
* Oversee the review and approval of non-conformances, CAPA, change controls, and complaints.
* Ensure batch records are reviewed and compliant with GMP and market authorization before release.
* Assist in preparing and updating technical agreements with licensees and contractors.
* Organize periodic reviews of QMS and operational procedures to ensure regulatory compliance.
Requirements
* Minimum 1 year experience in sterile manufacturing at an MIA site.
* Rélevant third-level qualification in Science or equivalent.
* Eligibility to act as a European Qualified Person (QP) certifying products in compliance with EU regulations.
Benefits
* Company pension scheme.
* On-site parking.
* Sick pay.