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Job Description
We are seeking a Senior R&D Quality Officer to oversee quality processes supporting on-site research and development activities at our Waterford site.
We touch the lives of over 200 million patients every day, and billions every year. We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.
The role involves ensuring quality processes are in place to support on-site research and development activities. Responsibilities include:
- Supporting new product introduction and ensuring system, process, and operations are in line with regulations and industry best practices.
- Investigating and closing out clinical customer complaints in a timely manner in accordance with cGMPs and company procedures.
- Ensuring software validation is carried out in compliance with site/corporate policies and SOPs.
- 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.
Requirements:
- Educated to Degree level in Pharmaceutical/Life Sciences.
- Experienced in a Pharmaceutical, Medical Device, or QA environment.
- Experienced in Regulatory/Notified Body inspections.
Desirable skills and knowledge:
- In-depth knowledge and understanding for interpretation 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. We are committed to a diverse and inclusive workplace for all.