AbbVie QA Specialist (12 month fixed term) in CARRIGTWOHILL, Ireland
QA Specialist (12 month fixed term)
Ireland, Munster, CARRIGTWOHILL
AbbVie employees work every day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people to be part of the team. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well.
We are currently sourcing a QA Specialist to join our Quality team in Carrigtwohill, Co. Cork on a 12 month fixed term contract. In this role, you contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
Implementation, maintenance and development of QA systems
Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc, and Exceptional Documents eg. NCRs/PNCRs, Planned Deviations etc
Writing and reviewing QA department procedures and reports eg. protocols, SOPs , environmental reports etc. Reviewing and Approving other departmental procedures and reports
Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management)
Alert the QA Compliance Manager in case of detection of a discrepancy / non compliance
Participation in change control activities on site
Assist in the preparation and reviewing of QA department reports and metrics eg. monthly quality report, discrepancy reports, exceptions reports, KPI reports
By reporting and communication to QA Compliance Manager on key events and issues etc. via normal in house reporting structure eg. meetings, formal reports etc
Participate in initatives and action plans for the development of QA and improvement of GMP compliance
Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
Assist in preparation and presentation of GMP training programmes
Represent QA on BeX projects to ensure compliance to GMP
Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP
Be the SAP Local Key User for the QA Department
Be the Site Lead for Isotrain System
Environmental Monitoring – review of data, monthly report , NCRs, Annual Report
Assist in New Product Introduction Activities when required
Contribute to the quality assessment of clinical, pre-commercial product, and IMPs
Contribute to the quality assessment of commercial finished product
Education & Experience:
Relevant 3rd level degree in science or quality
Minimum 3 years pharmaceutical experience in a regulated environment would be preferable.
Experience in pharmaceutical environment a significant advantage.
Knowledge of GMP.
Good organisation skills and time management.
Analytical approach to problem solving.