Quality Assurance Specialist
4 days ago
We are a leading biotechnology company, dedicated to harnessing the power of science and innovation to make a meaningful difference in people's lives. At Regeneron Ireland DAC, we strive to be at the forefront of pharmaceutical research and development, with a focus on creating life-changing treatments for patients worldwide.
Job Summary
We are seeking a highly skilled Quality Assurance Specialist (Csv Validation) to join our team. As a key member of our Quality Assurance organization, you will play a critical role in ensuring that our IT systems and programs meet the highest standards of quality and regulatory compliance.
This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional teams to drive business success while upholding the highest levels of quality and integrity.
Main Responsibilities
- Lead compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions
- Investigate and troubleshoot problems which occur and determine solutions for changes and/or improvements
- Review, edit and approve deviation notifications, investigations, and corrective actions
- Review, edit and approve change control and SOPs
Required Skills and Qualifications
To succeed in this role, you will need:
- Detailed knowledge of 21 CFR11 and Annex 11 as well as MHRA, FDA, and WHO data integrity guidelines
- Solid understanding and experience with Computer Systems Validation and/or IT Auditing
- Understanding of the interdependencies of change management, deviation, and continuous improvement
- Knowledge of global organizations, process mapping, and process improvement
Benefits
We offer a comprehensive benefits package, including: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
Others
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment where everyone has the opportunity to thrive.
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