Quality Assurance Specialist - GMP Compliance

Company Overview

Phibro Animal Health Corporation is a publicly traded international company specializing in animal health and nutrition products. Our portfolio includes medicated feed additives, vaccines, nutritional specialties, and mineral nutrition products. We partner with livestock producers, veterinarians, and consumers to support the health of farm and companion animals. Beyond animal health, we engage in manufacturing ethanol performance enhancers, microbials for various applications, and specialty chemicals across industrial markets. With revenues surpassing $1 billion and a workforce exceeding 2,300 employees globally, Phibro values its people and fosters an inclusive environment promoting creativity and professional growth.

Position Summary

The GMP Quality Assurance Specialist role is vital to our Ireland-based Sligo site, offering dedicated quality assurance support across manufacturing projects and strategic initiatives. Serving as the quality representative, the role ensures that GMP, regulatory, and Phibro's quality policies are embedded throughout project phases. The incumbent will facilitate qualification, validation, operational preparation, and continuous improvement efforts for commercial vaccine manufacturing, collaborating with cross-functional teams to guarantee timely and compliant project outcomes.

Core Responsibilities

• Function as the Quality Assurance liaison for assigned site projects and strategic programs.
• Incorporate GMP and company quality standards into all project activities and governance.
• Lead participation in project timing, risk assessments, and governance forums.
• Review and authorize qualification and validation documents, including protocols and reports.
• Oversee qualification activities concerning facilities, utilities, equipment, computerized systems, cleaning, and processes.
• Support the completion and closure of validation and qualification tasks.
• Assist in enhancing and implementing site quality management systems.
• Maintain adherence to GMP, data integrity, and Phibro’s quality standards.
• Contribute to the use and management of quality systems such as Veeva Vault and LIMS to support project execution.
• Evaluate and approve project-related GMP documentation ensuring readiness for inspections.
• Help develop SOPs and quality procedures operational at the site.
• Collaborate across Engineering, Technical Services, Operations, Regulatory Affairs, and Project Management departments.
• Provide guidance on quality-related changes, deviations, investigations, and corrective actions.
• Facilitate technology transfers, operational readiness, and regulatory inspection preparations.
• Participate as needed in audits, regulatory inspections, and related responses.
• Champion compliance with all applicable GMP, environmental health and safety (EHS), and corporate policies.
• Promote and support a proactive quality culture throughout the project lifecycle.

Required Qualifications and Experience

• Completion of a tertiary degree in scientific, engineering, pharmaceutical, biotechnology, quality, or related disciplines.
• At least 5 years of professional experience within a GMP Quality role, ideally at a manufacturing facility.
• Demonstrated experience supporting qualification, validation, manufacturing readiness, and technology transfer or enhancement projects.
• Sound understanding of GMP regulations, quality management systems, validation processes, change controls, deviations, CAPA, and data integrity.
• Proven ability to work effectively within interdisciplinary teams in a regulated manufacturing context.

Preferred Experience

• Background in supporting regulatory inspections, audits, and health authority engagements.

Work Conditions and Schedule

The position is located onsite at the Sligo facility in Ireland, with a standard work schedule from Monday through Friday, totaling 40 hours per week.

Diversity and Equal Opportunity

Phibro is committed to equal employment opportunities and considers all applications without discrimination based on race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status, or any other legally protected criteria.