Senior Quality Specialist, NPI
|Job Title:||Senior Quality Specialist, NPI|
|Contact Name:||Larry O’Leary|
|Job Published:||over 2 years ago|
required to lead and coach a Quality team, while managing multiple stakeholders and associated project teams, ensuring compliance of all new products transitioning into commercial manufacture through product development systems/processes.
The successful candidate will formulate quality strategy through the product development process - regulatory compliance, risk management, design control and quality systems; ensuring Product Development meets all applicable regulatory requirements.
This hire will be responsible for supervision and development of staff reporting to them in line with departmental and project goals.
From a technical perspective the ideal candidate will be an experienced leader quality systems and regulatory affairs, ensuring compliance of product from development to commercial manufacture. Expertise in managing risks associated with new products through their lifecycle and process improvement of such is required.
This is a permanent role with a medtech company based in Galway.
Requirements for Senior Quality Specialist, NPI:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline.
5+ years' experience in regulatory compliance or quality assurance role involving New Product Development and New Product Introductions.
People management and project management experience.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Proven Quality Systems knowledge and experience to FDA regulatory guidelines.
Please contact Larry on +353 1 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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