My client, a global pharmaceutical company now have an exciting new vacancy for a QA Manager.
The successful candidate will support the further development and implementation of a global quality management system, obtain local HPRA Authorisations such as MIA and help further promote a culture of Quality within all functional operations.
The primary responsibilities of this position include but are not limited to the following;
Support the establishment of a fit-for-purpose QMS system
Management of the components of the QMS, which consists of, but not limited to: change control, deviations, CAPAs, procedures, training, complaints, documentation, audits, inspections and vendor management.
Application for a Manufacturers and Import Authorisation (MIA)
Potential to help establish the process for Batch Release /QP Release activities from Dublin office
Support Global Pharmacovigilance, Regulatory Affairs, Clinical Development, Supply Chain, CMC Regulatory Affairs teams to ensure that QMS is compliant with applicable Global and EU regulatory requirements.
Be a key lead member during regulatory inspections and internal and external audits.
Compile and manage Quality metrics and KPIs.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to establish working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds.
Qualifications and Experience
Degree in Life Sciences.
Minimum 6 years experience in Quality environment in Pharma
Track record of QMS, SOP creation and audit/inspections.
Understands and maintains strong working knowledge of GxP, global regulations and guidelines for pharmaceutical companies.
Qualified QP Status is an advantage
Although primarily focusing on Medicinal Products, experience with Medical Devices is an advantage.
For full details and confidential discussion please email email@example.com or call +1 2784671