Regulatory Affairs Coordinator
An exciting opportunity for an experienced Regulatory Affairs Coordinator to join a leading packaging company based in Mallow, Cork on a permanent contract. The purpose of this role is to provide support to the Regulatory Affairs Manager in updating and maintaining compliance for all Company’s Health and Safety, Quality and Global Management Systems and ensuring accurate processes and procedures are in line with relevant legislation and company requirements.
- Support all Regulatory Affairs activities in the company.
- Implementation of company’s Quality, Health & Safety and Environmental policies in conjunction with corporate requirements.
- Maintain and assist in updates to site ISO 9001:2015 Quality Management System.
- Review and update site SOPs.
- Point of contact for customer concerns ensuring customer expectations are met and exceeded.
- Work with vendors on supplier quality complaints.
- Log and update corrective and preventive actions on site CAPA (Agile) system.
- Responsibility for new vendor set up, and maintaining site Vendor rating process.
- Assist in all site Vendor, Internal, Customer and Surveillance audits.
- Complete customer quality documentation (COA/COC etc.).
- Work with Production and Engineering Department to complete Installation, Operational and Process Qualifications (IOPQ) on new equipment and material produced on-site.
- Support Production Coordinator role during holidays & absences to process customer orders, book freight etc.
- 2-3 years working in Quality Control/Assurance roles.
- Experience in completing H&S activities in a manufacturing industry.
- Third-level qualification (scientific/technical discipline) or equivalent industry qualifications/certifications or experience.
- Experience with carrying out internal audits/vendor assessments etc.
- Experience with SAGE or other similar ERP systems.
- High level of proficiency in Microsoft software (Word, Excel, PowerPoint etc.).
For a confidential discussion and more information on the role, please contact Megan O’Doherty.