Quality Assurance Specialist - Biotech Site

About the role

PE Global is recruiting, on behalf of a leading biotech company based in Limerick, a Quality Assurance Specialist for an initial 12-month contract. The role helps maintain site compliance across manufacturing, quality systems, quality control, quality assurance, facilities, maintenance, engineering, materials handling and QA validation, in line with regulatory requirements and site expectations.

Key responsibilities

• Ensure compliance with all aspects of quality at the Raheen site, including manufacturing, quality systems, quality control, validation, facilities and materials management
• Maintain regulatory compliance in line with current Good Manufacturing Practices (cGMP)
• Review and approve failure investigations, CAPAs, SOPs, GxP documents and change control documents
• Lead and support root cause analysis so that appropriate CAPAs are implemented to prevent recurrence
• Review procedures, policies and other quality system documents for compliance with company policy and local and international regulations
• Monitor and trend metrics associated with site quality systems
• Take part in continuous improvement initiatives, internal, regulatory and customer audits, and train personnel on quality system processes
• Perform additional duties as requested

Required profile

• BS/BA in a scientific discipline or related field
• 2+ years of relevant work experience in the pharmaceutical or related industry, or an equivalent combination of education and experience
• Visa holders must have the right to live and work in Ireland; the client cannot assist with visa sponsorship

Candidates apply by submitting an updated CV through the recruiter's contact channel.