Job Reference: JO-2007-65313_1596035203
In this role, you contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
- 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 the 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 organization skills and time management
- Ability to critically assess issues and execute problem-solving
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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