[ref. l999117] Quality Specialist - Sligo

Industry: Biopharmaceuticals

About the Role:

Our client, a leading biotech company are seeking an experienced QA Specialist to join their growing Quality Assurance team. This is a fantastic opportunity to play a key role in maintaining high product quality standards in a regulated GMP environment while also supporting validation and qualification activities on-site.

Key Responsibilities:

• Serve as a technical QA advisor on GMP, validation, and compliance topics
• Manage core QMS processes including deviations, CAPAs, change controls, audits, and complaints
• Review and approve batch records, SOPs, and validation protocols/reports
• Support qualification activities for facilities, equipment, and utilities during start-up and routine operations
• Apply quality risk management principles to ensure compliance and project timelines
• Collaborate with cross-functional teams including QC, Manufacturing, and Engineering
• Drive 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)

Please note that this role can be offered on either a full-time or part-time basis, choose the hours that suit you!

Onsite role- flexible work