Job Description
QA Specialist Job Description We are seeking a highly skilled QA Specialist to support the Maintenance Department at Janssen Biologics in Cork, Ireland. The ideal candidate will have previous experience in a GMP environment and a strong understanding of quality assurance principles. **Key Responsibilities:** • Manage Quality Assurance activities at Janssen Biologics, adhering to Good Manufacturing Practice (GMP) regulations • Provide support and direction to all departments to ensure business, quality, and compliance goals are met • Partner with other departments to implement compliance systems efficiently • Conduct batch record reviews and material releases to ensure GMP compliance • Manage event management systems, including review and approval of events, deviations, and customer complaints • Administer the SAP Quality Management Module and manage site change control systems • Compile Annual Product Reviews and support validation activities on site • Approve and compile validation protocols and reports • Support system qualification and process validation activities • Perform GMP audits on-site and vendor facilities as required **Key Skills and Competencies:** • Excellent interpersonal skills and ability to operate as part of a team • Customer focus and innovative approach • Excellent communication skills, both written and verbal • Attention to detail and good problem-solving skills • Results-driven and adaptable, with a flexible approach to work • Decision-making skills and ability to apply GMP regulations and guidelines **Qualifications and Experience:** • Bachelor's degree in a scientific or technical discipline • Minimum of 3-5 years' experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry • Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals • Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position **Benefits:** • Paid holidays • Parking • Staff discounts