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Senior QA Specialist

Quality & Laboratory
Therese Keohane
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Job Reference: JO-2008-65351_1598436706


Our multinational Biopharma client is looking for a Senior QA Specialist to join a projects team working on a wide variety of initiatives, providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

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

* Own Quality record content
* Works under minimal direction
* Identify opportunities and issues, then determine when escalation is necessary
* Proposes revisions to SOPs in area of responsibility

Basic Qualifications:

* Min Bachelor's degree & 4 years of directly related experience
* cGMP Experience
* Ability to oversee multiple projects simultaneously
* Able to successfully manage workload to timelines
* 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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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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