Job Title: Senior Associate Quality for Computer Systems
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About the Role:
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We are seeking a skilled Senior Associate Quality for Computer Systems to join our team in Limerick. The successful candidate will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
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Key Responsibilities:
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* Maintain quality assurance procedures, policies, and systems.
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* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
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* Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
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* Investigate and address deviations, non-conformities, and CAPA to maintain quality.
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* Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
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* Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
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Requirements:
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To be considered for this position, you must have:
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* BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
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* Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
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* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
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* Excellent problem-solving and analytical skills.
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* Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV)
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What We Offer:
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We offer a competitive salary and benefits package, including opportunities for professional growth and development.
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Contact Us:
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Please send your CV in confidence to