Quality Assurance Lead, NPI
|Contact Name:||Larry O’Leary|
required to lead and coach a QA 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 is a permanent role with a blue-chip healthcare manufacturer based in Galway
Responsibilities of Quality Assurance Lead, NPI:
Supervision and development of staff reporting to them in line with departmental and project goals.
Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
Liaise with quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
Managing risks associated new products through their lifecycle and improvement of such.
Ensure Product Development compliance with quality policies.
Continually seeks to drive improvements in product and process quality.
Implement, maintain and update procedures that ensure that R&D documentation meets the company's Product Development Process and Control requirements.
Provides the quality/independent review at defined reviews, project plans, risk management, validation protocols and reports, for new development projects as well as process changes to existing products.
Requirements for QA Lead, 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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Key words; Quality Management, Quality Systems, NPI, Product Development, QMS, New Product Introduction, Product Launch, Commercial Launch, Design Control, Quality by Design, Medical Devices, Pharmaceutical, New Product Introduction, Galway, Clare, Connaught.