Quality Specialist

About CPi Biotech

CPi Biotech is an expanding Irish biopharma engineering firm located in Cork, specializing in manufacturing single-use technologies such as single-use assemblies and bioprocessing skid systems. Serving premier biopharmaceutical companies across Ireland, Europe, and North America, the company is growing its operations and client base.

Role Overview

Reporting to the Quality Lead, this role requires excellent collaboration skills to work across departments as part of a team. The primary focus lies in managing suppliers and customers to uphold compliance within the Quality Management System (QMS), operating within an ISO-certified environment aligned with cGXP standards.

Key Responsibilities

• Review and approve SOPs, work instructions, and documentation forms related to quality assurance
• Maintain and update essential QMS tracking tools consistently
• Prepare and implement timely actions for Change Control and Corrective and Preventive Actions (CAPA)
• Conduct batch record reviews and release materials, including Certificates of Analysis, ensuring GMP adherence
• Carry out internal and external audits effectively
• Participate in product release procedures
• Lead continuous improvement projects to enhance quality performance
• Contribute to the advancement of key performance indicators (KPIs)

Experience and Qualifications

• Minimum of 3 years in a quality role within GMP or regulated environments
• Backgrounds such as Bio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science are pertinent
• Holder of a scientific degree or qualifications in science, engineering, or technology
• Familiarity with customer and regulatory audits
• Previous experience in taking ownership of quality systems

Requirements

• Bachelor’s degree mandatory

Benefits

• Competitive salary and comprehensive benefits including company health insurance and pension scheme
• Prospects for professional growth within a fast-growing enterprise
• Supportive and dynamic workplace culture emphasizing career development
• Access to sports and social club activities
• On-site parking with electric vehicle charging facilities
• Availability of flexible work schedules

Additional Information

This position is critical to ensuring product quality and safety tailored for the biopharmaceutical market. It supports compliance with specifications required by multinational clients and protects the integrity of the supply chain and corporate interests. Candidates motivated to contribute to a pioneering biotech company's expansion are encouraged to apply.