QA Specialist Senior – REF NHA42

An opportunity has arisen for a Senior QA Specialist to join the quality team with a leading 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 (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)
• Escalate risks or roadblocks to management


Qualifications and Experience:
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• 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)


For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to [email protected]


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