QP/QA Specialist

Science & Pharmaceutical
Science & Pharmaceutical
Cork
Temporary
16599
Cork
Temporary
16599

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

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Josh Barnes
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