Job Description
Senior R&D Quality Officer role involves overseeing quality processes for on-site research and development activities, ensuring compliance with regulations and industry best practices.
We are a global pharmaceutical company committed to increasing access to high-quality healthcare to patients around the world. Our team in Waterford is responsible for supporting the development of new products and ensuring their quality.
The role of the Senior R&D Quality Officer is a diverse and challenging position that requires a strong understanding of quality processes, regulatory requirements, and industry best practices. The successful candidate will be responsible for:
- Supporting new product introduction and ensuring system, process, and operations are in line with regulations and industry best practice.
- Investigating and closing out clinical customer complaints in a timely manner, in accordance with cGMP's and company procedures.
- Ensuring software validation is carried out in compliance with site/corporate policies and SOP's.
- Providing Quality Assurance support for all clinical/submission batches, quality systems, IVBE studies, Device Design, Combination Products, and support for all new product development project teams.
- Providing guidance regarding clinical trial manufacture and new product development and introduction.
The ideal candidate will have:
- A degree in Pharmaceutical/Life Sciences.
- Experience in a Pharmaceutical, Medical Device or QA environment.
- Experience in Regulatory/Notified Body inspections.
The successful candidate will have:
- In-depth knowledge and understanding of cGMPs and Regulatory requirements for Combination Products / Medical Devices / IMPs.
- Experience with report writing, Project Management, Continuous Improvement, and problem-solving tools.
- Understanding of production and laboratory systems to effect judgment decisions consistent with quality and business needs.
- Knowledge and understanding of software validation/medical device requirements is desirable.
Teva Pharmaceuticals is committed to equal opportunity in employment and is an inclusive workplace for all.