required to lead process improvements to ensure predictable processes across all product lines, for our client a healthcare manufacturer based in Cork.
The successful candidate will lead complaint investigation and resolution for non-conforming product in manufacturing environment in line with CAPA system and GMP, and execute upgrades & change controls to our Quality System in line with FDA requirements.
This is a permanent role based in Cork.
Responsibilities of Quality Specialist:
Ensure Regulatory compliance in area of responsibility to cGMP?s and FDA regulations.
Review of document change orders to evaluate each change for quality related issues.
Review change controls, coordinate quality system batch reviews including CAPA?s.
Drive and implement process improvements to ensure predictable processes across all product lines Utilise Six Sigma, SPC, Lean Manufacturing and similar tools to analyse performance, identify areas for improvements and scope out projects.
Identification and implementation of appropriate statistical techniques to monitor process performance
Liaise with external groups in relation to complaint handling systems.
Maintenance of quality systems and validation projects as required.
Requirements of Quality Specialist:
Honours Bachelor?s Degree in; Science, Engineering, or similar honours degree discipline.
2-3 years industry experience in Quality role supporting manufacturing in GMP regulated environment.
Strong experience in dealing with CAPA?s, leading investigations into non-conforming product and leading audits.
Process Improvement and Validation experience are highly desirable.
Please phone Larry on 01-2302400 / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Key Words; FDA, GMP, Quality Assurance, Quality Engineer, ISO9001:2000, Compliance, Production, Manufacturing, Validation, Corrective Action, DOE, Statistical, Pharmaceutical, Medical Devices, Limerick, Cork, Waterford, Tipperary, Munster, Ireland.