Quality Process Specialist, NPI
|Job Title:||Quality Process Specialist, NPI|
|Contact Name:||Larry O’Leary|
|Job Published:||about 2 years ago|
required lead and implement process improvements across all product lines ensure delivery of highest quality product to the customer, in an FDA regulated GMP environment.
The successful candidate will provide Process Quality support to product development teams, helping to ensure development of highest quality new products.
This is a permanent role based in Munster region.
Responsibilities of Quality Process 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.
May be responsible for creating risk analyses and FMEAs.
Identifies and controls Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing CA/PAs.
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 and by performing appropriate analysis methods to enhance sustaining product design and new product development.
Ensure Regulatory compliance in area of responsibility to cGMP?s 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 Process Specialist:
Honours Bachelor?s 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 / 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.
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