Quality Compliance Specialist

6 days ago

Dublin, Dublin City, Ireland beBeeQualityManager Full time €65,000 - €82,000
Job Overview

This role oversees the quality and compliance of manufactured products, ensuring adherence to Good Manufacturing Practices (GMPs) and documentation standards.


Key Responsibilities
  • Review and approval of new and updated Master Batch Records/Electronic Batch Records for accuracy and compliance with cGMPs and company procedures.
  • Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with regulatory requirements and company guidelines.
  • Provide on-site support to ensure compliance and data integrity on the shop floor.
  • Review and approval of new and updated SOPs/Work Instructions and Controlled Job Aides to ensure consistency and accuracy.

Requirements
  • A minimum 5 years of relevant work experience in GMP Manufacturing, Quality Assurance, or Laboratory environments, preferably in Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory functions supporting manufacturing or laboratory operations.
  • Strong leadership skills combined with effective oral and written communication abilities.
  • A comprehensive understanding of cGMPs and regulatory requirements applicable to the pharmaceutical industry or related areas.

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