Quality Compliance Specialist

About the Role

We are seeking a Quality Compliance Specialist to join a leading global pharmaceutical company at their advanced manufacturing site near Westport, County Mayo, Ireland. This role is a 12-month contract opportunity with a growing organization dedicated to advancing healthcare through research and development.

Key Responsibilities

• Assist in managing the quality system to ensure that all personnel adhere strictly to its requirements.
• Support the implementation of a Quality Risk Management framework, including participation in Risk Control Strategies (RCS) and Failure Mode and Effects Analysis (FMEA) activities.
• Conduct audits of the quality system together with other management team members.
• Initiate and close quality-related event reports (ERs) as necessary.
• Provide expert quality guidance and approval concerning site and system validation activities.

Candidate Requirements

• Solid experience working in quality assurance roles within regulated environments.
• Comprehensive understanding of relevant regulatory standards and compliance obligations.
• Exceptional attention to detail coupled with strong mental focus to maintain procedural accuracy and compliance at all times.
• Demonstrated problem-solving ability and adaptability to evolving regulatory requirements.

Additional Information

This is an excellent chance to contribute to a significant project impacting life-changing medicines. Join a global team devoted to scientific innovation and healthcare advancement.