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QP

Quality & Laboratory
Cork
Claire McGuckin
Permanent
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Job Reference: JO-2007-65313_1596035203

Summary:

In this role, you contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.


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 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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Claire McGuckin
Claire McGuckin
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Quality & Laboratory
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