The appointed Quality Systems Specialist will be involved in all quality related tasks such as regulatory requests, quality agreements, management of external and internal audits, supplier investigations and documentation management. Further, they will provide quality oversight and support to all areas of Operations, Warehouse and Quality Control. The ideal candidate will have prior experience working in a GMP manufacturing environment.
- Provide quality systems support to all areas of the QMS
- Co-ordinate and oversee roles and responsibilities of existing quality team
- Manage regulatory and customer audits.
- Exercise judgment within defined procedures and practices to determine appropriate action.
- Provide support with supplier investigations and follow up CAPA
- Ensure compliance with cGMP, corporate standards/ Quality System (QS), site policies/procedures, regulatory requirements and industry standards.
- Participation in quality operations to ensure compliance and provide daily support
- Development and maintenance of SOP’s, Document Control, Change Notifications, Logbooks and Reports
- Provide Training as required
Education & Experience
- Quality / Science Qualification essential and 1-2 years’ relevant experience
- Excellent communication skills both written and verbal
- Experience in GMP manufacturing and Pharma environment an advantage.
For more information on the role and a confidential discussion, please contact Tina Egan