Temp Quality Compliance Specialist, QA Raw Materials

Regeneron Pharmaceuticals, Inc; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Temporary Quality Compliance Specialist to join the Quality Assurance Raw Materials team.

You will help ensure quality systems and regulatory compliance at the Raheen site. Responsibilities include reviewing investigations, change controls, CAPA, deviations and SOPs; maintaining electronic QA systems; monitoring quality metrics; and supporting internal and regulatory audits.

Qualifications

• BSc or BEng in a scientific field with 3+ years pharma experience.
• Experience in quality systems, deviations, CAPA and change control.

Responsibilities

• Ensure compliance with all quality aspects for the Raheen site and oversee site quality systems.
• Review and approve failure investigations, CAPAs, change controls, and SOPs.
• Maintain electronic systems for Change Control and Deviation Management.
• Review procedures, policies and other instructional documents for regulatory compliance.
• Monitor quality metrics and participate in continuous improvement initiatives.
• Participate in regulatory and customer audits and quality risk assessments.
• Collaborate with departments to resolve issues and maintain compliance.

Skills

Quality mindset

Attention to detail

Interpersonal skills

Regulatory compliance

Education

BSc / BEng in scientific field

Job description

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking a Temporary Quality Compliance Specialist to join the Quality Assurance Raw Materials team.

You will help ensure quality systems and regulatory compliance at the Raheen site. Responsibilities include reviewing investigations, change controls, CAPA, deviations and SOPs; maintaining electronic QA systems; monitoring quality metrics; and supporting internal and regulatory audits.