Our client, medical device manufacturer based in Galway, require a Quality Specialist to lead customer satisfaction projects regarding; customer complaints, investigations and defects in the Quality Department.
The successful candidate will work mainly on projects based role with work mainly with regards to New Product Introductions, managing tech transfers and associated validations & risk mitigation.
Responsibilities of 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 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 for Quality Specialist:
Honours Bachelors Degree in either; Science or Engineering.
3+ years experience working in Quality role in GMP manufacturing, ideally some of which working with FDA regulations.
NPI and manufacturing process transfer experience is highly desirable.
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, Clare, Galway, Roscommon, Mayo, Connaught.