Our client, a leading company in Longford, are seeking a PQA Team Leader.
Primary function/responsibility may focus on specific elements i.e.:
o Work closely with Site and Global PQA management to achieve Global and site specific goals
o Provide oversight of the site PQA Team and work closely with GPQA and site management
o Organise workload and set priorities for the site PQA team
o Provide and present monthly and ad hoc metrics
o Support Internal and External Audits and audit requests act as SME
o Initiate Customer Communications including Field Actions
o Support Vigilance Reporting (MDI/MDR) and Competent Authority Requests
o Perform Risk Evaluation, Customer Communication and FA
o Support the execution of Quality Holds, work closely with QAGCO
o Approve Complaint Evaluations, Trend Reports, Risk Evaluations, FA, QTC’s
o Develop PQA team members and provide performance reviews
o Assign and take training on time
Education & Experience
You will have a Third Level qualification or equivalent education in science or relevant quality discipline 5 years of experience in the support of technical operations, development, testing, manufacturing or quality areas preferably in a regulated environment.