Quality Risk Management Lead
An amazing opportunity has arisen for a Quality Risk Management Lead. This role will be responsible for driving the Integration and on-going consistency in Quality Risk Management in our state-of-the-art, single-use facility at Dunboyne Biologics.
Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.
What you will do :
- Integrate a harmonized global risk management program into Site Quality Management System
- Be the primary contact between the Global Quality Risk Management Organization and our Biologics site.
- Co-ordinate execution of risk assessments, risk control and risk communication and review
- Ensure site risk register and inventory is maintained and communicated
- Provide risk management training on site as required
- Provide periodic update to Quality Council on site risk status
- Lead the Site Quality Risk Management Council governance process
- Represent organisation at Industry forums
- Manage and participate in the preparation and hosting of regulatory and customer audits
What skills you will need :
- Minimum degree or post-graduate qualification (Science / Pharmacy / Engineering).
- 6-10 years’ working knowledge in Quality Assurance and Quality Risk Management Principles
- Understanding and practical application of GMP standards and regulations
- Working knowledge of Quality Risk Management regulations and best practices
- Seasoned in governance processes and management
- Proven record of influencing change
- Skilled supporting cross-functional investigations
- Analytical problem-solving skills
As a company, we are committed to Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to :
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
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