Quality Systems Specialist, Engineering (12M, Limerick)
QUALITY SYSTEMS SPECIALIST for ENGINEERING department required by CareerWise Recruitment for our multinational life sciences client at their facility in Limerick. Initial 12 month contract on offer and Hybrid working arrangement available.
The QUALITY SYSTEMS SPECIALIST for ENGINEERING will be responsible for Quality oversight and guidance for Senior Managers on capital projects. They will be responsible for establishment, maintenance and management of a control system for the specific Quality System(s)/Program.
NOTE: It is essential that you hold a valid working visa for Ireland.
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.
REQUIREMENTS:
* Degree qualified in a Science / Engineering discipline.
* 3+ years experience in a similar role.
Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering, Quality Assurance, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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