QA Associate

QCS Staffing Ltd; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

QCS Staffing Ltd in Cork is recruiting a QA Associate for a world-leading biopharmaceutical company. The role focuses on quality systems, compliance and regulatory processes within a state-of-the-art facility.

The successful candidate will manage deviations, CAPAs and change controls, monitor metrics, and participate in governance meetings to ensure timely closure and ongoing compliance across external quality systems.

Qualifications

• Bachelor's Degree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline.
• Extensive experience in a biopharmaceutical, pharmaceutical, medical device or other regulated environment.
• Experience in Quality, Compliance, Regulatory Affairs, Manufacturing Quality or a related function.
• Experience working with Quality Management Systems and regulated processes.

Responsibilities

• Perform the Quality Systems Metric Review for GEO and monitor performance, trends and emerging risks across External Quality systems.
• Manage and track Deviations, CAPAs, Change Controls, Risk Management records and associated actions to support timely closure and compliance.
• Facilitate routine cross-functional governance meetings to ensure quality records are progressed and closed within established timelines, with appropriate leadership endorsement.
• Develop, report and standardise quality system metrics across the organisation. Coordinate the monthly GEO Site Quality Review Team (SQRT) governance meeting and associated reporting activities.

Skills

Quality systems

Regulatory compliance

CAPA management

GEO/SQRT quality governance

Education

Bachelor's Degree in Science, Engineering, Quality, Pharmaceutical Sciences or related discipline

Tools

Quality Management System

Job description

QA Associate – Ireland, Cork – Long Term Contract – Life Sciences

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Our client is currently seeking a QA Associate.

What You’ll Deliver

• Perform the Quality Systems Metric Review for GEO and monitor performance, trends and emerging risks across External Quality systems.
• Manage and track Deviations, CAPAs, Change Controls, Risk Management records and associated actions to support timely closure and compliance.
• Facilitate routine cross-functional governance meetings to ensure quality records are progressed and closed within established timelines, with appropriate leadership endorsement.
• Develop, report and standardise quality system metrics across the organisation. Coordinate the monthly GEO Site Quality Review Team (SQRT) governance meeting and associated reporting activities.

Key requirements:

• Bachelor's Degree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline.
• Extensive experience in a biopharmaceutical, pharmaceutical, medical device or other regulated environment.
• Experience in Quality, Compliance, Regulatory Affairs, Manufacturing Quality or a related function.
• Experience working with Quality Management Systems and regulated processes.