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QA Specialist GMP

Phibro Animal Health Corporation -
Sligo, County Sligo

Apply Now

Job details

Qualifications

Engineering
Technical writing
Quality systems
Manufacturing

Full job description

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

The QA Specialist GMP is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.

Position Details

PURPOSE
Provide dedicated Quality Assurance support to site project activities and strategic initiatives within the Sligo manufacturing facility.
Serve as the Quality representative for assigned project workstreams, ensuring GMP, regulatory, and Phibro quality requirements are incorporated throughout project execution.
Support qualification, validation, operational readiness, and continuous improvement activities impacting commercial vaccine manufacturing.
Partner with Manufacturing, QC, Engineering, Validation, Regulatory Affairs, Supply Chain, and project teams to ensure compliant and timely project delivery.
Ensure quality risks are identified, assessed, and managed throughout the project lifecycle while maintaining inspection readiness and site compliance.

KEY RESPONSIBILITIES

Serve as the QA representative for assigned site projects and strategic initiatives.
Ensure GMP and quality requirements are incorporated into project activities.
Participate in project governance, planning, and risk assessments.
Ensure GMP and quality requirements are incorporated into project activities.
Participate in project governance, planning, and risk assessments.
Review and approve qualification and validation protocols and reports.
Provide QA oversight for facility, utility, equipment, computerized system, cleaning, and process qualification activities.
Support execution and closure of qualification and validation activities
Support implementation and enhancement of site quality systems.
Ensure compliance with GMP, data integrity, and Phibro quality standards.
Support Veeva Vault, LIMS, and other quality systems required for project execution and operational readiness.
Review and approve project-related GMP documentation.
Ensure quality documentation is complete, compliant, and inspection-ready.
Support development of SOPs and operational quality procedures.
Partner with Engineering, TSA, Operations, Regulatory Affairs, and Project Management teams.
Provide quality guidance for change controls, deviations, investigations, and CAPA activities.
Support operational readiness and technology transfer initiatives.
Support facility GMP approval and regulatory inspection readiness activities.
Participate in audits, inspections, and regulatory responses as required.
Ensure compliance with applicable GMP, EHS, and company requirements.
Promote a strong quality culture throughout project execution.

KEY COMPETENCIES
Strong understanding of GMP compliance, quality systems, validation requirements, and manufacturing site quality standards
Knowledge of facility, utility, equipment, computerized system, cleaning, and process qualification activities within a regulated manufacturing environment
Ability to operate effectively in a site project environment with multiple stakeholders, deadlines, workstreams, and competing priorities
Strong documentation review and technical writing skills, including protocols, reports, deviations, CAPAs, SOPs, and project documentation

EDUCATION & EXPERIENCE
Essential

Third-level qualification in a scientific, engineering, quality, pharmaceutical, biotechnology, or related discipline.
Minimum 5 years' experience working in a GMP Quality environment, preferably within a manufacturing site.
Experience supporting qualification, validation, manufacturing readiness, technology transfer, or site improvement projects.
Working knowledge of GMP regulations, QMS, validation lifecycle, change control, deviations, CAPA & data integrity requirements.
Experience working within cross-functional teams in a regulated manufacturing environment.

Desired

Experience supporting regulatory inspections, audits & health authority interactions.

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit: Animal Health & Mineral Nutrition
Division: Animal Health & Nutrition
Department: Quality Assurance
Location: Ireland - Sligo
Work Schedule: Monday - Friday (40 Hours)

Apply Now

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