Compliance Monitoring Professional
3 days ago
This Compliance Monitoring Professional will work under the Quality Assurance organization at Regeneron Ireland Dac, responsible for ensuring IT systems and programs are compliant with regulatory requirements.
The role will involve collaboration with IT and QA teams to ensure all aspects of IT-related programs comply with regulatory expectations and internal policies.
Key responsibilities include:
- Leading compliance monitoring of operations, including trending of failures and evaluating corrective actions
- Investigating and troubleshooting problems, determining solutions for changes and/or improvements
- Reviewing, editing and approving notifications, investigations, and corrective actions
- Reviewing, editing and approving change control and SOPs
- Supporting Quality Risk Management (QRM) principles in risk assessment initiatives
- Supporting Quality Assurance Agreement (QAA) development and review
To be successful in this role, you should have knowledge of 21CFR11 and Annex 11, as well as data integrity guidelines from regulatory agencies.
A background in Computer Systems Validation and/or IT Auditing is also essential.
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