Job Description
Required to provide process quality support to the product development team, leading and implementing process improvements across all product lines ensure development of highest quality new products, to FDA requirements.
The ideal candidate will be a person with strong problem solving methodologies, who is self-motivated and very driven to alleviate any quality concerns or issues. Candidates with good attitude and a proven history of success in quality will be an ideal fit.
This is a permanent role based in Munster region.
Responsibilities of Quality Specialist:
Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
Query & bound data to support implementation of complex & documenting release criteria.
Identifies and controls Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing CA/PAs.
Develop and lead risk analyses and FMEAs.
Identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
Leads process improvement efforts by identifying methods to capture quality metric data, through performing appropriate analysis methods to enhance sustaining product design and new product development.
Ensure Regulatory compliance in area of responsibility to cGMPs of all regulatory agencies (e.g. FDA, etc.).
Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
Perform internal quality audits.
Requirements for Quality Specialist:
Honours Bachelors Degree in Science, Engineering or related technical discipline.
4+ years Quality Assurance / Quality Engineering experience in a manufacturing environment, preferably GMP regulated.
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 / larry@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. www.rftgroup.ie