Quality

Quality Systems Manager

Quality Systems Manager, Galway Our client, an innovative Medtech company based in Galway, now seek an experienced Quality Systems Manager to lead associated team working within Quality systems, with responsibilities for Quality Management, Internal and External Audits in FDA regulated cGMP manufacturing environment. The successful candidate leads/manages inspection activities of the Quality System related to regulatory agencies and/or notified bodies, across numerous global markets. Responsibilities for Quality Systems Manager Lead ISO/MDD quality systems standards, constantly promoting awareness of best industry practices. Leads/manages internal audits of the Quality System th...

Job Type:

Permanent

Location:

Galway

Salary:

N/A

Job Ref:

123772

Associate Director, Quality Assurance Management

Associate Director, Quality Assurance Management Our client, a pharmaceutical manufacturer company based in Connaught, now seeks a suitably experienced Associate Director of Quality Assurance Management who will provide effective leadership across the business, contributing to strategic programs and developing a high performing quality operations team in an FDA regulated environment. The successful candidate will manage the Quality function, with oversight of a large Operations area that is generating significant revenue. Additional responsibility for all things Supplier Quality, Compliance and Auditing, Operational Excellence, Continuous Improvements and Program Management in l...

Job Type:

Permanent

Location:

Galway

Salary:

N/A

Job Ref:

123694

QA Specialist - Responsible Person

QA Specialist - Responsible Person 12 months contract role The QA Specialist - Responsible Person will be part of the Quality Systems team within Technical Operations organisation based in Dublin. The role covers the distribution aspects of the Irish Wholesale Distribution Authorisation (WDA). Responsibilities Ensure that operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the Dublin site WDA Ensure the conditions of the Wholesale Distribution Authorisation are maintained Support the preparation, implementation and on-going maintenance of the QMS systems and op...

Job Type:

Contract

Location:

Dublin

Salary:

N/A

Job Ref:

123790

Manufacturing Supervisor - Biologics

Manufacturing Supervisor – Biologics My client a leading Pharmaceutical company now require a Manufacturing Supervisor – Biologics to join their expanding team. The Manufacturing Supervisor – Biologics will act as the operations team lead in a new regenerative medicine manufacturing facility, they will support the development of the site operational structure particularly with regards to regenerative medicines manufacturing. They will report directly to the Manufacturing Manager. This is a permanent position based in Dublin and comes with a strong salary and benefits package. Manufacturing Supervisor – Biologics Lead the operations team of plant technologists in biologics manufa...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

123788

QP Qualified Person

Qualified Person Perm Part-time Dublin. QP release and certification of all assigned products within the EU & other relevant markets; assuring that the DP batch has been manufactured and checked in accordance with the requirements of its MA and in accordance with the principles and guidelines of GMP & any other legal requirements. Product Certification & Release should be performed in accordance with 2001/83/EC (as amended) and 2001/82/EC (as amended). QP and batch release activities should be in accordance with EU GMP Annex 16: Certification by a Qualified Person and Batch Release. Identify deficiencies in product quality and quality systems. Review and approval of Annual Produ...

Job Type:

N/A

Location:

Dublin

Salary:

N/A

Job Ref:

123782