Job Description
Our client, a blue-chip multinational company based in Cork, now seek an Lead Quality Specialist to provide technical leadership to Quality personnel overseeing all Quality issues within manufacturing on NPIs, within an FDA regulated environment.
The successful candidate will lead quality programme regarding new product introductions to site, scale-up to manufacturing and all associated validations - driving six sigma initiatives to continuously improve processes in line with lean programme on site.
Responsibilities of Lead Quality Specialist, NPI:
Lead transfer and implement product and processes from development or from another manufacturing facility.
Project manages a number of QA projects in line with the implementation of Lean Manufacturing programme across the site.
Manage customer complaints, process validations, regulatory documentation, perform internal quality audits.
Implement and drive process improvements to ensure predictable processes across all product lines.
Provide effective and responsive QA support to Operations to meet their KPIs.
Implement and drive and implement plant wide quality system improvements.
Identification and implementation of appropriate statistical techniques to monitor process performance.
Approval of change requests for product, process and quality system changes.
Ensure Regulatory compliance in area of responsibility to cGMP's.
Requirements for Lead Quality Specialist, NPI:
Honours Bachelor's Degree in Science, Engineering, or equivalent.
4+ years Quality experience in GMP environment, of which at least 2+ years' experience in FDA / ISO 9000 regulated environment.
Proven experience in the management of QA systems.
Ideally candidates will be experienced in product verification & process validations.
Proven Project Management skills.
Please contact; 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 / www.meddevicejobs.ie
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Key Words; FDA, GMP, Engineering, Engineer, Quality Engineering, Senior Quality Engineer, QA Engineer, Quality Management, Compliance, Six Sigma, Process Validation, CAPA, DOE, Pharma, Medical Devices, Munster, Cork, Limerick, Tipperary, Waterford, Ireland.