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QCS Staffing

Quality Compliance Specialist

QCS Staffing

Westport, Connecticut, United States · 정규직

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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.

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