Job Description
required to lead & project manage quality service projects within manufacturing environment, for our client based in Galway.
The successful candidate will lead investigations into customer complaints, to minimise recurring complaints and complete all associated documentation in a GMP environment.
All Quality issues are resolved in line with the CAPA system for the site.
Responsibilities for Quality Specialist:
Ensure regulatory compliance with appropriate guidance documents.
Review of document change orders to evaluate each change for quality related issues.
Review change controls, coordinate quality system batch reviews including CAPA?s.
Maintenance of quality systems and validation projects as required.
Drive operational efficiency through inter-departmental & cross-functional projects.
Requirements of Quality Specialist:
Honours Bachelors Degree in; Sciences, Engineering or similar.
4+ years experience in resolving customer complaints through leading investigations, in line with a Quality Management System.
Strong experience in using problem solving tools, preferably six sigma or similar.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation.
For Further details please contact Larry on 01-2302400 / larry@rftgroup.ie / 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; Customer Complaints, Investigations, Product Defects, Product Validation, Cleaning Validation, CAPA, Compliance, GMP, FDA, Clare, Limerick, Athlone, Westmeath, Galway, Mayo, Sligo, Connaught.