required lead and implement process improvements across all product lines, in an FDA regulated GMP environment.
The successful candidate will be tasked with leading; risk reduction, yield improvements, customer complaint reduction, error proofing, cost reduction initiatives and process automation activities.
This is a permanent role based in Munster region.
Responsibilities of Quality Specialist:
Ensure Regulatory compliance in area of responsibility to cGMP’s of all regulatory agencies (e.g. FDA, etc.).
Provide effective and responsive QA support to Operations to meet business KPIs.
Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
Drive and implement plant wide quality system improvements.
Transfer and implement product and processes from development or from another manufacturing facility.
Approval of change requests for product, process and quality system changes.
Analysis of returns, approval of analysis reports and analysis of complaint trends.
Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
Review of MRB trends and identification of appropriate corrective actions when required.
Perform internal quality audits.
Requirements for Quality Specialist:
Honours Bachelor’s Degree in Science, Engineering or related technical discipline.
3+ years’ experience in a manufacturing environment, preferably GMP regulated.
2+ years’ experience in QA role within FDA regulated environment is ideal.
Strong Project Management skills.
Proven experience with problem solving and process improvement methodologies, e.g. Six Sigma, etc.
Excellent interpersonal and communication skills.
Please phone 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.
|Job Title:||Quality Engineer|
|Contact Name:||Larry O'Leary|
|Job Published:||over 4 years ago|