Validation And Compliance Manager
5 days ago
We are a leading biotechnology company with a strong commitment to scientific innovation and patient care. Our mission is to deliver life-changing treatments that 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 high-quality treatments that meet the needs of patients worldwide.
Job Role
The Quality Assurance Specialist (Csv Validation) plays a critical role in ensuring the quality and integrity of our IT systems and programs. 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
- Oversee compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions
- Develop and implement effective quality assurance strategies to mitigate risks and drive business growth
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry best practices
Requirements
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
- Ability to work collaboratively in a fast-paced environment and adapt to changing priorities
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.
Equal Opportunities Employer
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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