Quality

QA Audit Manager, GxP

QA Audit Manager, GxP An innovative biopharmaceutical organisation, focused on discovering and developing new therapeutics, now seek to expand their team with the appointment of a QA Audit Manager. The successful candidate will be involved in maintaining, developing and continually improving the company Quality Management System (QMS) and ensuring a Quality culture is present throughout the organisation. The ideal candidate will have a track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. Travel (approximately 10-20% depending on operational activities) domestic and/or international. Responsibilities of QA Audit M...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

122949

Regulatory Affairs Officer

Regulatory Affairs Officer Our client, a pharmaceutical company based in Dublin, now seeks a Regulatory Affairs Officer to ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures. The successful candidate will be responsible for assisting in the preparation, creation and submission of new Marketing Authorisation Applications, variations and RFIs to the HPRA, MHRA and other Regulatory Authorities, in compliance with regulations & guidelines. Responsibilities of Regulatory Affairs Officer: Compile appropriate documents/files etc. for submission to regulatory authorities/external...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

122948

Quality Assurance Lead, People Manager role

Quality Assurance Lead, People Manager role Our client, a blue-chip multinational healthcare manufacturer based in Galway, seeks a Quality professional to lead engineering principles to product quality assurance, software quality assurance and design quality assurance to support an effective overall quality system. The successful candidate will provide customized technical support service which meets Quality and Compliance requirements while driving internal and external customer satisfaction across; Calibration, Supplier Assurance, Product Analysis, and other similar technology areas. Responsibilities of Quality Assurance Lead, People Manager: Lead customer satisfaction project...

Job Type:

Permanent

Location:

N/A

Salary:

N/A

Job Ref:

122939

R&D Quality Assurance Specialist

R&D Quality Assurance Specialist Our client a innovative medical devices manufacturer based in Galway, now seeks a Quality Assurance Specialist to manage the transition of products from R&D through to commercial launch, exercising risk management associated with the design, use and manufacture. Scope of role: product development and related sustaining engineering activities, across a number of product areas. This hire will require strong communication skills with ability to work in cross-functional teams, interfacing with R&D, Clinical, Marketing, Process Development and Manufacturing in a project core team environment providing technical and Quality systems input to the team. R...

Job Type:

Permanent

Location:

Galway

Salary:

N/A

Job Ref:

122938

NPI Quality Specialist

NPI Quality Specialist Our client, a blue-chip multinational company based in Cork, now seek an experienced NPI Quality Specialist to provide technical leadership to a team of junior Quality personnel regarding all Quality issues within this manufacturing environment. This is a permanent role. The successful candidate will overseeing all issues within manufacturing on existing products & new product from development and associated tech transfers, within an FDA regulated environment. Responsibilities of NPI Quality Specialist: Manage customer complaints, process validations, regulatory documentation, perform internal quality audits. Lead transfer and implement product and process...

Job Type:

Permanent

Location:

Cork

Salary:

N/A

Job Ref:

122937