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QA Specialist

Quality & Laboratory
Dublin South
Siobhán Lane
Temporary
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Job Reference: JO-2102-65593_1612773730

Summary:

The QA Specialist will provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Responsibilities:

* Manage and own NC records for External Quality

* Manage and own CAPA records for External Quality

* Manage and own Change Control records internal to External Quality

* Manage and drive Quality records to closure independently

* Perform tactical batch disposition activities in support of lot release

* Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed

* Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)

* Escalate risks or roadblocks to management

* Drive timely decision making using DAI principles

* Drive continuous improvements

* Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)

Requirements:

* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry with Bachelor's Degree in a Science Field

* cGMP Experience

* Ability to oversee multiple projects simultaneously

* Able to successfully manage workload to timelines

* Familiarity with basic project management tools

* Ability to negotiate a position after taking feedback from multiple sources

* Demonstrated ability to consistently deliver on-time, and high-quality results

* Ability to operate in a matrixed or team environment

* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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