Quality Team Lead
|Job Title:||Quality Team Lead|
|Contact Name:||Larry O’Leary|
|Job Published:||about 1 year ago|
required to manage a Quality team, overseeing all issues on products within commercial manufacture and supporting product development teams, helping to ensure development of highest quality new products, in an FDA regulated GMP environment.
The successful candidate will manage the Quality team on; performance and output quality review, development and training of all Quality personnel.
This is a permanent role based in Munster region.
Responsibilities of Quality Team Lead:
Ensure effective and responsive support from Quality team to Operations to meet business KPIs.
Drive and implement plant wide quality system improvements.
Lead Quality team in transfer and implement product and processes from development or from another manufacturing facility.
Reduces and controls Manufacturing process defects by leading efforts/teams focused on identifying the primary root causes and implementing CAPAs.
Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.
Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
Review of MRB trends and identification of appropriate corrective actions when required.
Responsible for the final Process Monitor Release for products prior to distribution.
Requirements for Quality Team Lead:
Honours Bachelor's Degree in Science, Engineering or related technical discipline.
5+ years' experience in a manufacturing environment, preferably GMP regulated.
Ideally 2+ years' experience of which in Quality role within FDA regulated environment.
Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
Experience with problem solving and process improvement methodologies, e.g. Six Sigma, etc is desirable.
Excellent interpersonal and communication skills.
Please phone Larry on 01-2302400 / firstname.lastname@example.org
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
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Key words: QA, Quality Assurance, Quality Engineering, Product Development, corrective and preventative actions, New products, quality systems, quality plans, risk analysis, FMEAs, Process improvement, nonconforming, customer complaints, Cork, Tipperary, Waterford, Munster.