Senior Quality Specialist

About the role

CPi Biotech, a fast‑growing Irish biopharma engineering company, is seeking a Senior Quality Specialist to join its Little Island headquarters in Cork. Reporting to the Quality Lead, you will work cross‑functionally to ensure compliance with the Quality Management System (QMS) and maintain product safety for global biopharma customers.

Key responsibilities

• Investigate and document non‑conformances, driving root‑cause analysis.
• Draft, execute, and track Change Control and CAPA actions.
• Maintain QMS tracking tools and ensure batch record review and material release meet GMP standards.
• Review and approve SOPs, work instructions, and forms.
• Manage supplier approvals and coordinate customer/supply‑chain notifications.
• Plan and conduct internal and external audits.
• Support product release activities and continuous improvement initiatives.

Required profile

• 3‑5+ years of experience in a Quality function within a GMP‑regulated environment.
• Scientific or engineering degree (e.g., Bio‑pharma, Medical Device, Nutraceutical, Food Science).
• Direct exposure to customer and regulatory audits.
• Strong collaborative mindset and ability to work across functions.

Required skills

• CAPA management
• Change Control processes
• Good Manufacturing Practice (GMP) compliance
• ISO 9001/ISO certified environment
• Batch record review and Certificate of Analysis (CoA) handling
• Supplier approval procedures
• Audit execution (internal and external)
• SOP review and approval

What we offer

• Competitive salary and benefits package
• Opportunities for career advancement in a rapidly expanding company
• Dynamic, supportive work environment focused on professional growth