Head of Quality – GMP - Athlone
A senior quality professional is required to lead a highly capable and talented team in this successful pharmaceutical manufacturing site.
Responsibilities include management and supervision of the Quality Control and Quality Assurance functional activities, working alongside the Qualified Person on release activities. Qualified Person qualification is essential.
This role will suit someone with a respected leadership style, who enjoys developing people and is comfortable in a hands-on role.
Key Responsibilities:
1. Oversee the Quality Assurance and Quality Control Teams.
2. Support implementation, maintenance and continual improvement of the company's Quality Management System as appropriate.
3. Ensure an effective compliant Quality Management System is in place on site to ensure best possible outputs in terms of site compliance and throughput of product.
4. Undertake the role of Qualified Person named on the relevant Manufacturing Licence(s) as authorized by the Competent Authority.
5. Perform Qualified Person certification of product for release to market, as necessary to meet business requirements and in accordance with the Purchasing release schedule.
6. Site quality operations and batch certification:
* Manage and coordinate activities of the Quality team ensuring all arrangements are in place for the allocation of activities to ensure compliance and timely batch release.
* Ensure Review (or delegate) batch documentation relating to the manufacture and testing of each product batch in accordance with the relevant release procedures and confirming certification of product batches by recording in the relevant Qualified Person register.
Requirements:
* Eligible to be named on a Manufactures Licence as Qualified Person.
* Quality Management and leadership experience in the pharmaceutical industry.
* Desirable: QC experience; Regulatory experience.