Quality Specialist

CPI Biotech; Cork; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Health Scheme

Pension Plan

Career advancement

Supportive work environment

Sports & Social Club

On-site parking

EV charging access

Flexible working

Job summary

CPi seeks a Quality Specialist to join our expanding team at the Little Island, Cork HQ. This permanent, site-based role reports to the Quality Lead and focuses on supplier and customer management, maintaining QMS compliance in an ISO-certified environment to ensure product quality and supply security.

You'll work cross-functionally on Change Control, CAPA, audits, and batch release, contributing to KPI improvements and supporting a rapidly growing bio/pharma customer base.

Qualifications

• 3+ years in a Quality function within GMP/regulated environment.
• Bio/pharma, medical device, nutraceutical, or food science background.
• Bachelor-level science/engineering qualification.

Responsibilities

• Drafting and timely execution of actions for Change Control and CAPA
• Update of key QMS tracking tools
• Batch Record Review and material release to ensure GMP compliance
• QA review and approval of SOPs, Work Instructions, and Forms
• Execution of internal and external audits
• Product release activities
• Contribution to KPI metrics improvements
• Update of key tracking tools for QMS

Skills

Quality management

GMP compliance

Audits

Document control

Education

Bachelor’s degree in science, engineering, or technology

Job description

We are looking to recruit a Quality Specialist to join our expanding team. The position is permanent and is site-based in our Headquarters, in Little Island, Cork. The successful candidate would be joining the company at a key and exciting time in the company’s growth as we expand our operations and customer base.

About the Role

Reporting to the Quality Lead, this position requires an effective collaborator to work cross-functionally and as part of a team. With a strong focus on supplier and customer management, this role will facilitate continuing compliance with the QMS. Working in an ISO-certified environment, CPi endeavours to excel by also matching cGXP guidelines through shared ownership and execution of the QMS. This role is key to maintaining the quality and safety of products for the bio/pharmaceutical market, ensuring the company meets the specification requirements of its multinational customers, and assuring the security of the supply chain and the company’s interests.

Key Responsibilities

• Drafting and timely execution of actions for Change Control and CAPA
• Update of key tracking tools for QMS
• Batch Record Review and material release (includingCoA) to ensure compliance with GMP requirements
• QA Review and Approval of SOPs, Work Instructions, and Forms
• Execution of internal and external audits
• Product release activities
• Contribution to improving KPI metrics
• Update of key tracking tools for QMS

Experience & Qualifications/Requirements

• 3 years + in a Quality function in a GMP/regulated environment
• Bio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science background
• Bachelor’s degree/Graduate with a scientific degree or qualifications in science, engineering, or technology
• Exposure to customer/regulatory audits
• Prior experience of system ownership
• Candidate must also be authorized to work in Ireland

• Competitive salary and benefits package, including Company Health Scheme and Pension Plan
• Opportunities for career advancement in a rapidly expanding company
• A dynamic, supportive work environment with a focus on professional growth
• Sports & Social Club
• On-site parking, including access to EV Charging
• Flexible working arrangements