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Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2011-65450_1604651055



* Reviewing the GMP documentation such as SOPs, reports, methods, specifi-cations, validation protocols, quality contracts, etc., and Exceptional Doc-uments e.g. NCRs/PNCRs, Planned Deviations, etc.

* Participating and follow-up of audits and/or inspections carried out at the site by the authorities or clients, propose corrective actions, and check that they are applied

* Writing and reviewing QA department procedures and reports e.g. proto-cols, SOPs, environmental reports, etc. Reviewing and Approving other de-partmental procedures and reports

* Internal Auditing (when required) of FLI Departments and external audit-ing (when required) of Material and Service Suppliers (including Supplier Management)

* Notifying the QA Compliance Manager in case of detection of a discrepan-cy/noncompliance

* Participation in change control activities on site

* Assisting in the preparation and review of QA department reports and met-rics 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, for-mal reports, etc.

* Taking part in initiatives and action plans for the development of QA and improvement of GMP compliance

* Assisting in preparation and presentation of GMP training programs

* Representing QA on BeX projects to ensure compliance with GMP

* Ensuring QA activities are executed in line with in-house procedures and compliance with requirements of cGMP

* Acting as the SAP Local Key User for the QA Department

* Environmental Monitoring - review of data, monthly report, NCRs, Annual Report

* Collaborating with New Product Introduction Activities when required

* Contributing to the quality assessment of the clinical, pre-commercial product, IMPs, and commercial finished products


* Third level qualification in a science discipline with 5 years experience in the healthcare/pharmaceutical industry

* MSc in Industrial Pharmaceutical Science or a similar course recognized by the Regulatory Authority to permit Qualified Person (QP) status

* Experience to the requirements for a 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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Siobhán Lane
Siobhán Lane
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Quality & Laboratory
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