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Regulatory Compliance Specialist

1 week ago

Kilbeggan, County Westmeath, Ireland Matrix Recruitment Group Full time

About the Job

This is a fantastic opportunity to join a dynamic team and contribute to the growth of a pharmaceutical start-up in Westmeath. As a Senior Quality and Validation Specialist, you will be responsible for ensuring regulatory compliance and leading validation and qualification activities.

Company Overview

Our client is a rapidly expanding pharmaceutical company that values innovation and excellence. They are committed to developing high-quality products that meet the needs of their customers.

Key Duties and Responsibilities

  • Lead validation and qualification of equipment, utilities, facilities, and computerised systems.
  • Develop and execute validation protocols, cleaning validation, and process validation.
  • Oversee the Quality Management System (QMS) and maintain SOPs and work instructions.
  • Conduct internal audits, regulatory inspections, and risk assessments.
  • Investigate and close validation deviations, non-conformances, and CAPAs.
  • Provide technical leadership and collaborate with cross-functional teams.

Requirements

  • Essential experience with HPRA and EU GMP Annex 11 & 15.
  • Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
  • 4-8 years' experience in pharmaceutical or biotech manufacturing, with expertise in validation and quality management.
  • Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
  • Experience with equipment/facility qualification, computerised system validation, and data integrity compliance.