Product Quality Specialist

2 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €75,000 - €105,000
Quality Assurance Professional

Enhance product quality standards in a regulated environment.

About the Role:

You will serve as a technical advisor on GMP, validation, and compliance topics. Manage core QMS processes, review batch records and SOPs, and support qualification activities for facilities and equipment.

Key Responsibilities:
  • Technical QA advising on GMP, validation, and compliance topics
  • Managing core QMS processes including deviations, CAPAs, change controls, audits, and complaints
  • Reviewing and approving batch records, SOPs, and validation protocols/reports
  • SUPPORTING QUALIFICATION ACTIVITIES FOR FACILITIES, EQUIPMENT, AND UTILITIES DURING START-UP AND ROUTINE OPERATIONS
  • Applying quality risk management principles to ensure compliance and project timelines
  • Collaborating with cross-functional teams including QC, Manufacturing, and Engineering
  • Driving continuous improvement initiatives across QA processes
Requirements:
  • Bachelor's degree (or higher) in a scientific or engineering discipline
  • Minimum 5 years' experience in QA within a GMP-regulated pharmaceutical or life sciences environment
  • Hands-on experience with validation and a solid grasp of regulatory requirements
  • Strong technical writing skills (SOPs, deviations, validation documentation)
  • Excellent communication skills and ability to work independently and in cross-functional teams
  • Fluent in English (written and spoken)

This is an onsite role that can be offered on either a full-time or part-time basis, choose the hours that suit you.

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