Quality

Pharmacovigilance Officer (PV Officer)

Location: Dublin Office-Based with option for working from home Term: 12-month contract role (with a view to permanency) SUMMARY Responsible for the support of activities related to our client's Pharmacovigilance system, compliance with global Regulatory Health Authorities, adverse event reporting, safety contracts, and reconciliations. Role involves support for both commercially marketed and development products, and oversight of client’s distributors/vendors to ensure compliance. REPORTS TO Qualified Person for Pharmacovigilance (QPPV) and Deputy (QPPV) ESSENTIAL FUNCTIONS: Support with oversight of services provided by our client’s pharmacovigilance vendor, ensuring complianc...

Job Type:

Contract

Location:

N/A

Salary:

N/A

Job Ref:

123888

Quality Assurance Manager

Quality Assurance Manager – 12 month contract – Dublin The QA Manager is responsible for supporting the creation, execution and maintenance of quality management systems (QMS) to ensure adherence to Quality standards and Regulatory requirements for their commercial and development products/projects which encompass, small and large molecule products. This position provides strategic and tactical management of Quality activities collaborates with cross-functional team members and or contract manufacturers and external service providers. This position reports to the Quality Director to provide robust and timely Quality and Regulatory support that aligns across functions to execute ...

Job Type:

Contract

Location:

Dublin

Salary:

N/A

Job Ref:

123906

Supplier Quality Specialist

Supplier Quality Specialist My client a leading and rapidly expanding Pharmaceutical Company now require a Supplier Quality Specialist to join their rapidly expanding team. The Supplier Quality Specialist will represent Quality to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. This is an initial contract position based in Galway with strong package and good possibility of being made permanent. Responsibilities of Supplier Quality Specialist Provides engineering support for activities related to supplier selection and evaluation, material qualification, supplier ...

Job Type:

N/A

Location:

Galway

Salary:

N/A

Job Ref:

123901

Quality Specialist

Quality Specialist The QA Specialist will support the quality oversight of the QA biologics development and external function. This includes all quality aspects at contract manufacturing operations for clinical and commercial manufacturing to ensure that the operational business follows cGMP, the Quality agreement, regulatory requirements and Quality Management system. Responsible for ensuring new biologic drug development programmes are following EU/FDA and associated guidance’s Responsible for ensuring consistency to management of the CMO and for ensuring the CMO is in compliance with the regulatory requirements and company standards. ESSENTIALS AREAS OF RESPONSIBILITY: Serve ...

Job Type:

N/A

Location:

Dublin

Salary:

N/A

Job Ref:

123897

QA Specialist -Senior

Senior Specialist Quality Assurance Reporting to the Director, Device Quality, this is an advanced position requiring significant expertise/specialisation in area with responsibility for day to day implementation of Quality Systems and Compliance functions appropriate for our client’s combination products. The Senior Quality Specialist will be capable of working on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to Emergent products. May assist with compliance audits as required. (pa...

Job Type:

Permanent

Location:

N/A

Salary:

N/A

Job Ref:

123894