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Job Description
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:
- Supporting the digitalization and automation of quality systems to drive data insights and process innovation
- Managing internal audit programs and ensuring compliance with regulatory requirements
- Supporting the implementation of next-generation quality systems
- Managing the nonconformance system and CAPA process
- Supporting site regulatory inspections
- 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:
- Analytical and critical problem solver
- Collaborator and a teammate
- Strategic problem solver
- Problem solving and attention to detail
- Results and performance driven
- Integrity, transparent and objective
- Customer focused
- Clear social skills
- Adaptable and flexible
- Innovative
- Inclusive, facilitative style
Qualifications and experience:
- Third-level qualification (scientific/ engineering/ IT/ BIS field required)
- Experience with one or more data analytics techniques and tools
- Minimum of 3-5 years experience within the biological and/or pharmaceutical/ medical device industry
- Knowledgeable of FDA/EMEA regulatory requirements
Benefits:
- Paid holiday
- Parking
- Staff Discounts