Job Description
Our client, a blue-chip multinational healthcare manufacturer based in Galway, seeks a Quality professional to lead engineering principles to product quality assurance, software quality assurance and design quality assurance to support an effective overall quality system.
The successful candidate will provide customized technical support service which meets Quality and Compliance requirements while driving internal and external customer satisfaction across; Calibration, Supplier Assurance, Product Analysis, and other similar technology areas.
Responsibilities of Quality Assurance Lead, People Manager:
Lead customer satisfaction projects regarding; customer complaints, investigations and defects in the Quality Department.
Ensure all Quality issues are highlighted and resolved in line with the stability programme and CAPA system for the site.
Review of document change orders to evaluate each change for quality related issues.
Review change controls, coordinate quality system batch reviews including CAPAs.
Maintenance of quality systems and validation projects as required.
Provide guidance to Quality Engineering group on pharmaceutical/combine product stability issues.
Contribute to making the operation efficient and compliant by effective liaison with quality control, engineering, production and manufacturing.
Ensure regulatory compliance with appropriate guidance documents.
Requirements of Quality Assurance Lead, People Manager:
Honours Bachelor's Degree in either; Science or Engineering.
6+ years' experience working in Quality role in GMP manufacturing, ideally some experience working with FDA regulations.
Proven experience in the management of CAPA and Change Control programmes is desired.
Ideally experienced in Product Transfers or New Product Introductions, and Process Validation.
Experienced with problem solving tools / methodologies
Six Sigma certification is desirable.
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.
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Key words; QA Engineer, Quality Engine, Quality Specialist, Customer Complaints, Investigations, Product Defects, Product Validation, Validation, CAPA, Compliance, GMP, FDA.