Life Science Compliance Professional

19 hours ago

Limerick, Limerick, Ireland beBeeCompliance Full time €60,000 - €70,000
Job Summary

We are seeking a seasoned professional to join our team as a Compliance Specialist. In this critical role, you will support the Quality Control organization in meeting compliance targets through laboratory investigation and deviation management.

Key Responsibilities:

  • Coordinate preparation for regulatory inspections and internal audits, ensuring the Quality Control department is audit ready at all times.
  • Act as the primary point of contact during inspections or audits, addressing inquiries and providing documentation as needed.
  • Organize and maintain quality records, including Change Controls, CAPAs, and Workflows.
  • Lead cross-functional teams during Change Control or CAPA events, ensuring alignment on strategies and resolution plans.
  • Review, edit, and revise controlled documents to ensure compliance with written procedures and regulatory standards.
  • Monitor open compliance records to ensure timely resolution and closure.
  • Report quality system metrics to relevant departments to track performance and identify improvement areas.
  • Represent Quality Control in interdepartmental teams and meetings, ensuring QC perspectives and requirements are considered.
  • Perform other duties assigned by Quality Control management, demonstrating flexibility and a broad understanding of QC functions.
Requirements
  • Bachelor's degree in Life Sciences or equivalent required.
  • Minimum 2 years of experience in the pharmaceutical or biotechnology industries preferred.
  • Excellent verbal and written communication skills required.

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