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Compliance Specialist Senior

3 weeks ago

Cork, Cork, Ireland beBee Careers Full time
Job Description

Senior Compliance Specialist - Job Overview

We are seeking a Senior Compliance Specialist to join our team. This role will be responsible for executing the internal audit program, preparing and leading external audits, providing compliance subject matter expertise and deploying compliance initiatives at the site.

The ideal candidate will have a minimum of 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience. A solid understanding of global GMP regulations is required.

  • Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).
  • Responsible for training and qualifying auditors.
  • Facilitate and support external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.
Key Responsibilities
  • Inspection Readiness: lead compliance walk-throughs, audit preparation, coaching the SMEs.
  • Provide compliance subject matter expertise and compliance training to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.
  • Implement compliance initiatives and projects at the site, in alignment with Global Innovative Medicine Regulatory Compliance (IMRC).
  • Partner with site to proactively identify risks and drive compliance improvement across the site.
Qualifications and Requirements
  • A minimum of a Bachelor's Degree or equivalent experience in Science or related field.
  • At least 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.
Benefits

This position offers a unique opportunity to work in a dynamic environment and contribute to the success of the organization. The successful candidate will be rewarded with a competitive salary package and opportunities for professional growth and development.