To implement and maintain Quality Assurance actions in compliance with the current GMP regulations.
- Implementation, maintenance and development of QA systems
- Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc
- Writing and reviewing QA department procedures and reports
- Internal Auditing of FLI Departments and external auditing of Service Suppliers
- Participation in change control activities on site
- Assist in the preparation and reviewing of QA department reports and metrics
- Environmental Monitoring – review of data, monthly report , NCRs, Annual Report
- Assist in New Product Introduction Activities when required
- Contribute to the quality assessment of clinical, pre-commercial product
- Contribute to the quality assessment of commercial finished product
- Relevant 3rd level degree in science or quality
- Minimum 3 years pharmaceutical experience in a regulated environment would be preferable.
- QP certification advantageous
- Experience in pharmaceutical environment a significant advantage.
- Knowledge of GMP.
- Good organisation skills and time management.
- Analytical approach to problem solving.
If you meet the desired criteria above please send your CV to email@example.com or phone 01 4744676 for a confidential discussion.
This is not a graduate role.