QA Specialist

QA Specialist required for Life Sciences client based in Limerick. Initial 12 month contract.

Responsibilities: 

• Quality oversight of and guidance 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

Requirement:

• 5+ years experince in similar position
• May hold BSc, MSc, in Chemistry, Engineering or related discipline

Please contact James Farrar today for further information email: jfarrar@careerwise.ie

CareerWise Recruitment (In Search of Excellence)Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.