Our Client, Multinational company based in Cork are currently recruiting for QA Specialist role (12 month fixed term contract) . In this role you will contribute to the implementation and maintenance of QA actions in compliance with the current GMP regulations.
· Implementation, maintenance and development of QA systems
· Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, vali-dation 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 com-pliance
· 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 is-sues etc. via normal in house reporting structure eg. meetings, formal reports etc
· Participate in initiatives and action plans for the development of QA and improve-ment 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
· Ensure QA activities are executed in line with in-house procedures and in compli-ance 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
· Relevant 3rd level degree in science or quality
· Minimum 3 years pharmaceutical experience in a regulated environment would be preferable.
· QP certification advantageous
· Experience in pharmaceutical environment a significant advantage.
· Knowledge of GMP.
· Good organisation skills and time management.
· Analytical approach to problem solving
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255