Quality Engineer – GMP/Aseptic Compliance

Biopharma Careers; Ireland; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work

On-site role in Tralee

Job summary

Astellas is seeking a Quality Engineer for its on-site role in Tralee, Ireland. The role focuses on ensuring GMP/GDP compliance for an aseptic fill-finish facility, collaborating with Validation, Engineering, Facilities, QC, and QA regulatory teams.

Hybrid working options are available to balance office and home working. The candidate will develop procedures, perform risk assessments, prepare regulatory submissions, and support audits while driving continuous quality improvement.

Qualifications

• Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.

Responsibilities

• Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
• Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment.
• Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
• Support internal/external audits, ensuring timely issue resolution, and raise/review non-conformances.
• Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence.
• Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions.

Skills

Quality Assurance

GMP/GDP

Regulatory compliance

Risk assessment

Data analysis

Education

Engineering or Science degree

Job description

Astellas is seeking a Quality Engineer for its on-site role in Tralee, Ireland. The role focuses on ensuring GMP/GDP compliance for an aseptic fill-finish facility, collaborating with Validation, Engineering, Facilities, QC, and QA regulatory teams.

Hybrid working options are available to balance office and home working. The candidate will develop procedures, perform risk assessments, prepare regulatory submissions, and support audits while driving continuous quality improvement.