Quality Compliance Specialist
Westport, Connecticut, United States · Tempo total
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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.