QA Specialist GMP

Phibro Animal Health; Sligo; On-site; EUR 70,000 - 90,000; Full time

Job summary

Phibro Animal Health is seeking a dedicated Quality Assurance professional to provide QA support for site projects at the Sligo facility. You will act as the QA representative, ensuring GMP and quality requirements are embedded in all project activities and documentation.

The role covers qualification, validation, and manufacturing readiness activities, with collaboration across Manufacturing, QC, Engineering, Regulatory Affairs, and Supply Chain to ensure compliant, timely project delivery and

Qualifications

• 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.

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.
• 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.

Skills

GMP compliance

Quality systems

Validation requirements

Education

Bachelor's degree or higher in a relevant field

Tools

Veeva Vault

LIMS

Job description

Position Details

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.
• 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 (39 Hours)