PACIV, a global leader in industrial automation solutions with offices in Ireland, Puerto Rico, and the United States, and serving the Life Science, F&B and Utilities industries, is looking for a Quality AssuranceEngineer for its Ireland office.
Quality oversight of and guidance for pharmaceutical area on capital projects
Maintenance of all aspects of GMP compliance for the area(s) of responsibility
Establishment, maintenance and management of a control system for the specific Quality System(s)/Program
Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program
Review and approval of change controls and failure investigations, associated with the area(s) of responsibility
Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility
Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility
Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
Please send CV to email@example.com
PLEASE NO AGENCIES AT THIS TIME
Experience - 5 to 10 years
BSc, MSc, in Chemistry, Engineering or related discipline.