Headcount Solutions Limited

Senior QA Specialist (BB-A5E4F)

Found in: Neuvoo Irlanda

QA Specialist SeniorAn 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 managementQualifications 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 (phone number removed) or email your CV in the strictest confidence to

calendar_today2 days ago

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location_onDublin, Ireland

work Headcount Solutions Limited

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