Quality Engineer

About the Role and Company

Astellas Pharma is a global leader in the life sciences industry, dedicated to transforming innovative scientific research into impactful therapies primarily in oncology, ophthalmology, urology, immunology, and women's health. The company pioneers healthcare solutions focusing on diseases with significant unmet needs.

This role is a 12-month fixed-term contract based in Tralee, Ireland. The position demands full onsite presence in the office and requires flexibility to work extra hours or travel depending on business needs.

Purpose and Responsibilities

The Quality Engineer is responsible for supporting the operations department by ensuring strict compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards within an aseptic fill finish manufacturing facility. Key duties involve adherence to relevant regulations, internal policies, and industry best practices. This position collaborates closely with teams from Validation, Engineering, Facilities, Quality Control, and other support functions to sustain compliance.

Key Responsibilities

• Maintain compliance with regulatory, legislative, and statutory obligations while promoting awareness throughout Operations.
• Create and maintain operational procedures to uphold best practice and regulatory standards, including conducting risk assessments on equipment and processes.
• Prepare necessary documentation and data for Annual Product Quality Reviews, regulatory submissions, investigations of customer complaints, and routine evaluations.
• Assist with both internal and external audits by ensuring prompt resolution of issues and managing the initiation and review of non-conformance reports.
• Offer technical quality support for operations through investigations, root cause identification, and corrective actions to aid production continuity and scheduling.
• Contribute to plant-level activities such as Change Control, commissioning, qualification, and collaboration with Quality Assurance regulatory teams for submission processes.

Required Qualifications

• Possession of a third-level qualification in Engineering or a Science discipline, or equivalent substantial relevant experience in related fields.

Work Environment and Values

• Engage globally within a community committed to patient-centered outcomes.
• Impact patients' lives worldwide by supporting the development of transformative therapies.
• Participate in a culture that encourages innovative thinking and pushing operational boundaries.
• Benefit from a workplace that fosters career growth, development, and progress.
• Embody organisational values including Impact, Innovation, Integrity, One Astellas team spirit, Accountability, Courage, Sense of Urgency, and Outcome Focus.

Additional Information

Astellas is an equal opportunity employer embracing diversity without discrimination on any legally protected basis. Applicants should be vigilant about recruitment scams, as official communications will only originate from verified company email addresses or official profiles.