Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support Janssen Sciences Ireland in delivering GMP‑compliant products. You will work across departments to ensure quality systems meet business and regulatory goals.

Key responsibilities

• Review batch records and release incoming material in line with GMP requirements.
• Administer event management, including deviations, customer complaints and change control.
• Maintain the SAP Quality Management module and support site validation activities.
• Compile Annual Product Reviews and approve validation protocols and reports.
• Review and approve SOPs, work instructions and forms from other functions.
• Coordinate preparation for regulatory and customer GMP inspections.
• Participate in New Product Introduction teams and conduct GMP audits.

Required profile

• Experience working in a GMP‑regulated environment.
• Ability to collaborate with multiple departments and follow J&J leadership standards.

Required skills

• SAP Quality Management module.
• Knowledge of GMP requirements and documentation.
• Understanding of validation processes (analytical, cleaning, equipment, etc.).

What we offer

• Inclusive work environment that values diversity and individual merit.
• Opportunities to contribute to innovative healthcare solutions.