HRM has been retained by a leading global Pharmaceutical and Medical Devices organisation based in Dublin West, to recruit an experienced Quality Manager to join the Quality team.

The Quality (QA) Manager has responsibility for the implementation and performance of the Quality Management System (QMS) for the company, and has management responsibilities for the QA team in the Dublin West operation.

The Role

Duties and responsibilities of the Quality Manager will include:

• Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents
• Maintain Quality processes in support of company authorisations (WDA, MIA, ASR)
• Ensure processes are maintained as Marketing Authorisation Holder (MAH)
• Provide QA expertise and manage any Quality issues that arise to closure
• Lead HPRA inspections and prepare written responses to inspections
• Lead internal compliance audits of the operation
• Prepare and approve HPRA variations
• Review and approve Non Conformances (NC), CAPA, change controls and complaints
• Deputy Responsible Person (DRP) for Wholesale Distribution Authorisation (WDA)
• Develop, maintain and approve Quality Agreements in order to ensure that these are current, retrievable and meet the global Quality standards for Quality Agreements
• Initiating of change control proposals as required
• Manage QA Team

The Person

You will have skills and experience in the following:

• 7+ years' experience in GMP/GDP environment
• People manager
• Strong knowledge of GxP regulations
• Hands on experience implementing Quality Systems in a GxP environment
• Ability to communicate effectively with all levels of the organisation and its customers
• Experience with MAH role a plus

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.