- Reference: GJ334422
- Job Type: Permanent
- Location: Galway, Galway City, Mayo
- Category: Medical Devices
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
Within the Quality Engineering Validation Department, we focus on execution of process validation activities that exceed the requirements and expectations of patients, physicians, regulatory agencies and the business. The Quality Engineering Validation Department is directly involved in the development of the validation strategies and execution of the validation activities releasing novel processes and products to commercialization.
You will take a lead role in the planning and the execution of process validation activities for new products, technology transfers and improvement projects. You will play a key role in providing Quality input into new product development, process improvements and change control. You will support the characterization and risk assessment of manufacturing processes and associated equipment. You will work with project team members to establish process controls that ensure the safety and efficacy of the product. You will be an extended team member on PDP projects, representing the Quality Engineering function. You will liaise with cross functional team members, developing strong partnering relationships with these groups. You will develop and maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, validation, technology transfer and commercialisation activities. You will lead and support root cause driven approaches to problem solving efforts for quality issues. You will use and establish analysis techniques and other quality tools to aid decision making.
We are looking for a person qualified to a Level 8 Third Level Degree in Science, Engineering or related discipline and desirably with 5 – 8 years relevant experience or 3 – 6 years relevant experience with a relevant Master’s Degree. You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced with the ability to be self-directed and to effectively interface with various levels and functions within the organization. Ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable. Having broad technical expertise and knowledge of interrelated quality function disciplines and a high level of aptitude in QE/QA principles and methodologies is advantageous. A good working knowledge of process validation requirements would be beneficial. Some experience or background in combination or pharmaceutical products would also be beneficial. You are a good communicator and fluent in English, both in writing and speaking.
Leadership Expectations provide the framework for what we expect from all employees – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
■ Demonstrates Global Business Acumen
■ Thinks Critically and Makes Sound Decisions
■ Sets Strategic Direction
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
■ Collaborates and Creates Alignment
■ Attracts, Deploys, and Develops Talent
■ Fosters Diversity and Inclusion
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
■ Focuses on Patient and Customer
■ Generates Breakthrough Ideas
■ Initiates and Leads Change
We do what we say we are going to do, delivering results with the highest standards.
■ Sets High Standards
■ Instils Operational Excellence
■ Drives Accountability
■ Models Ethical Behavior