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Snr QA Specialist

Quality & Laboratory
Dublin
James Roche
Contract
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Job Reference: JO-2109-65961_1631089183

Summary:

Do you possess 5+ years Biopharmaceutical manufacturing experience within a GMP environment? If so, you could be the perfect candidate for this 12 month contract with a world class biologics client of ours in their external supply quality group.

Description

Provide 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

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

Basic Qualifications:

* Doctorate degree OR

* Master's degree & 2 years of directly related experience OR

* Bachelor's degree & 4 years of directly related experience OR

* Associate's degree & 10 years of directly related experience OR

Preferred Qualifications:

* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry

* Bachelor's Degree in a Science Field

* cGMP Experience

* Ability to travel +/- 10% of time to domestic and international sites

Key Must haves:

This is a L5 role so they would need to be able to have previous 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)

*Trackwise is the system used onsite

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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James Roche
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