Quality Assurance Engineer
|Job Title:||Quality Assurance Engineer|
|Contact Name:||Larry O’Leary|
|Job Published:||about 5 years ago|
required to lead customer satisfaction projects regarding; customer complaints, investigations and defects in the Quality Department.
Quality Specialist will ensure all Quality issues are highlighted and resolved in line with the stability programme and CAPA system for the site.
This role is with a blue-chip multinational healthcare manufacturer provider based in Galway.
Responsibilities of Quality Assurance Engineer:
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 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.
Requirements of Quality Assurance Engineer:
Honours Bachelors Degree in either; Science or Engineering.
4+ years experience working in Quality role in GMP manufacturing, ideally some of which 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 / firstname.lastname@example.org / 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.
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