Head of Quality – GMP - Athlone
A new position has arisen for an experienced Head of Quality for this successful pharmaceutical manufacturing site to lead a highly capable and talented team.
Responsible for management and supervising the Quality Control and Quality Assurance functional activities and working alongside the QP on release activities. QP qualification is required.
This role will suit someone with a respectful leadership style, who enjoys developing people and is comfortable in a hands-on role.
Responsibilities:
• Oversee the Quality Assurance and Quality Control Teams.
• Support implementation, maintenance and continual improvement of the company QMS as appropriate.
• Ensure an appropriate compliant QMS is in place on site to ensure best possible outputs in terms of site compliance (including Regulator Inspections) and throughput of product
• Undertake the role of QP named on the relevant MIA(s) as authorized by the Competent Authority.
• Perform QP certification of product for release to market, as necessary to meet business requirements and in accordance with the Purchasing release schedule.
• Site quality operations and batch certification:
o Manage and co-ordinate activities of the Quality team ensuring all arrangements are in place for the allocation of activities to ensure compliance and timely batch release.
o 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 QP register.
Requirements:
• Eligible to be named on a manufactures licence as Qualified Person
• Quality Management and leadership experience in the pharmaceutical industry
• QC experience desirable;
• Regulatory experience desirable.
Apply:
Send CVs in confidence to [email protected]
