
Compliance Officer
1 week ago
Job Summary:
We are seeking an experienced Quality Assurance Specialist to join our team in Ireland. This role will be responsible for ensuring compliance with GxP requirements and ISO 9001 2015 standards.
About the Role:
The Quality Assurance Specialist will support the development and implementation of processes and systems to maintain quality standards. Key responsibilities include:
- Maintaining the Electronic Quality Management System across the business and contributing to achieving KPI targets.
- Managing deviations and CAPAs, risk management, and change control as part of the quality team.
- Acting as Deputy Responsible Person for Wholesale Distribution Authorisations.
- Assisting in preparation for Regulatory and Client Audits.
- Contributing to the integration of QMS into Business Units.
- Analyzing data associated with the performance of the Quality System.
- Maintaining Licenses, including Manufacturing licenses and Wholesale Distribution Authorisation.
- Training business units on quality and compliance matters.
- Reporting metrics associated with the Quality Management System.
- Prioritizing activities within required timelines.
- Identifying and addressing compliance issues proactively.
Requirements:
To be successful in this role, you will need:
- A degree in Life Sciences.
- Experience in Quality Assurance and Quality Management systems.
- Familiarity with GxP requirements and ISO 9001 2015 standards.
- Previous experience as Deputy RP.
- A full driver's license.
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