Posted on Jan 31, 2021 by Real Staffing Group
Job title: Quality Manager
Location: Shannon, Co.Clare
Benefits: Excellent salary, Health insurance, PRSA, Opportunity to grow your career in an exciting company.
Company: Founded in 2010 my client are certified to both ISO 9001,2015 for the provision of Consultancy Services and ISO 13485, 2016 for Design. Development and Manufacture of Bone Substitute materials
* Promote a culture of Quality Compliance on site
* Manage a team of Quality Assurance and Quality Control professionals
* Lead the preparation for, and hosting of, external audits from Competent Authorities and Notified Bodies
* Manage the site self-inspection and annual internal audit programs
* Lead the Quality Management Review Process
* Oversee compliance with 2017/745, ISO 13485, ISO 9001 and FDA QSR requirements
* Manage all Client Quality Process'
* Drive the implementation of new processes particularly in the QC department, namely Incoming Inspection, in-process testing, release testing, retain management, data trending of same.
* Management of 3rd party test laboratories
* Ensuring all company policies, procedures, housekeeping and health and safety rules are adhered to.
* Actively contributing to cross functional teams on special projects as required.
* Tracking of all KPI
* Perform technical review of data generated through manufacturing, laboratory, validation protocols and reports
* Lead investigations out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools and to implement effective corrective and preventative actions.
* Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects.
* Ensuring that the quality system is fully aligned with business objectives and are changed, maintained and improved to support business needs on an ongoing basis.
* Support Audit Readiness Activities
* Any other responsibilities as may be required by Area Director
Qualifications and Education Requirements
* Minimum of 7 years of experience in cGMP Quality environment.
* A degree in Science, Engineering or a related discipline
* Certified Internal Auditor
* Experience in managing/leading teams
* Good knowledge of current regulatory requirements for QA and QC in support of GMP operations supporting clinical and commercial manufacturing (essential)
* Experience in Quality Risk Management (desirable)
Would you be interested in discussing this opportunity in more detail?
If you are interested in this position forward me your up to date CV and we can organsie a call to discuss further.
Look forward to hearing from you
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales