Quality Systems Specialist needed to support digitalization and automation of quality systems, drive data insights, and innovate processes in a hybrid role at Janssen in Cork.
The role involves supporting the implementation of next-generation quality systems, managing internal audit programs, and ensuring compliance with regulatory requirements.
Key responsibilities include:
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Supporting the digitalization and automation of quality systems to drive data insights and process innovation
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Managing internal audit programs and ensuring compliance with regulatory requirements
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Supporting the implementation of next-generation quality systems
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Managing the nonconformance system and CAPA process
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Supporting site regulatory inspections
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Providing support, direction, and training to all departments in respect of specific quality system elements
The ideal candidate will have a broad knowledge of c GMPs, prior experience of working in HPRA/FDA regulated facilities, and excellent analytical and critical problem-solving skills.
Key competencies required:
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Analytical and critical problem solver
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Collaborator and a teammate
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Strategic problem solver
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Problem solving and attention to detail
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Results and performance driven
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Integrity, transparent and objective
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Customer focused
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Clear social skills
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Adaptable and flexible
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Innovative
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Inclusive, facilitative style
Qualifications and experience:
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Third-level qualification (scientific/ engineering/ IT/ BIS field required)
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Experience with one or more data analytics techniques and tools
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Minimum of 3-5 years experience within the biological and/or pharmaceutical/ medical device industry
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Knowledgeable of FDA/EMEA regulatory requirements
Benefits:
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Paid holiday
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Parking
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Staff Discounts