Quality Specialist

About the role

CPi Biotech is seeking a Quality Specialist to join its fast‑growing team in Cork. Reporting to the Quality Lead, you will work cross‑functionally to ensure compliance of the Quality Management System (QMS) and support the safety and quality of biopharmaceutical products.

Key responsibilities

• Review and approve SOPs, work instructions, and forms.
• Maintain and update QMS tracking tools.
• Draft and execute actions for change control and CAPA.
• Review batch records and release materials, including Certificates of Analysis, to meet GMP requirements.
• Conduct internal and external audits.
• Participate in product release activities.
• Drive continuous improvement initiatives and contribute to KPI metrics.

Required profile

• Minimum 3 years experience in a Quality function within a GMP/regulated environment.
• Scientific degree (e.g., Bio/Pharmaceutical, Medical Device, Nutraceutical, Food Science) or related engineering/technology qualification.
• Experience with customer and regulatory audits.
• Prior ownership of quality systems.

Required skills

• GMP compliance
• cGXP guidelines
• ISO standards
• Change Control processes
• CAPA management
• Batch Record Review

What we offer

• Competitive salary and benefits, including health scheme and pension.
• Opportunities for career advancement in a rapidly expanding biotech company.
• Dynamic, supportive work environment focused on professional growth.
• Sports & social club, on‑site parking with EV charging.
• Flexible working arrangements.