Senior QA Specialist – REF NHA56

An opportunity has arisen for a Senior QA Specialist within a renowned Dublin based biopharmaceutical multinational.  The successful candidate will 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
• 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
• Train on required Quality Systems

Qualifications and Experience:

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry (med device will also be considered)
• 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)

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