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Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2010-65413_1602146196



* Ensure that products manufactured on site meet requirements of end-users, Regulatory Authorities, and the company.

* Review and maintain adherence to manufacturing and testing processes including validation, production conditions, and manufacturing records.

* Oversee any deviations or planned changes in production or QC and ensure authorization is in accordance with defined systems and relevant authorities.

* Confirm that all necessary checks and tests have been performed, including that all additional sampling, inspection, etc. have been initiated due to deviation or planned change.

* Inspect all necessary production and QC documents to ensure they have been completed and endorsed by authorized team members.

* Ensure all audits have been carried out as required by the quality assurance system.

* Account for all factors relevant to the quality of the batch taking necessary action when appropriate.

* Maintain knowledge and experience of all technical and scientific progress and changes in quality management relevant to the products including requirements to certify an unfamiliar batch of product type such as a new product range being introduced prior to certification.

* Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.

* Drive team compliance to procedures, policies, and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines at all times.


* Third level qualification in a scientific discipline with 5 years' experience in the pharmaceutical industry.

* MSc in Industrial Pharmaceutical Science or a similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.

* 5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment.

* Desirable: 2 Years' experience gained within an aseptic processing environment, ideally gained within a quality function.

* Experience assessing day to day quality issues across products and processes.

* Strong decision making and the ability to work with autonomy.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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