QP/QA Specialist

We are currently recruiting for a QP/QA Specialist to join the Quality team in a leading Pharmaceutical organisation. In this role, you contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.

Role Responsibilities:

• Implementation, maintenance, and development of QA systems
• Reviewing the GMP documentation egg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc., and Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc
• Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports etc. Reviewing and Approving other departmental procedures and reports
• Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management)
• Alerting the QA Compliance Manager in case of detection of a discrepancy / noncompliance
• Participation in change control activities on site
• Assist in the preparation and reviewing of QA department reports and metrics e.g. monthly quality report, discrepancy reports, exceptions reports, KPI reports
• Reporting and communication to QA Compliance Manager on key events and issues etc. via normal in-house reporting structure e.g. meetings, formal reports etc.
• Participation in initiatives and action plans for the development of QA and improvement of GMP compliance
• Follow-up of audits and/or inspections carried out at the site by the authorities or clients
• Assist in preparation and presentation of GMP training programs
• Represent QA on BeX projects to ensure compliance to GMP
• Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP
• Be the SAP Local Key User for the QA Department
• Be the Site Lead for Isotrain System
• 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, and IMPs
• Contribute to the quality assessment of commercial finished product.

Education & Experience:

• Relevant 3rd level degree in science or quality
• Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16
• Previous management/supervisory experience advantageous
• Experience of GMP auditing and documentation
• Good organisation skills and time management
• Ability to critically assess issues and execute problem solving

For a confidential discussion and more information on the role, please contact Josh Barnes.

josh.barnes@collinsmcnicholas.ie

021-4911066