QA Specialist

Phibro Animal Health SA; Sligo; On-site; EUR 60,000 - 85,000; Full time

Job summary

Phibro Animal Health Corporation in Ireland (Sligo) is seeking a QA Specialist to ensure GMP-compliant manufacturing and regulatory alignment. You will review batch records, support investigations of non-conformances, approve change controls, and drive continuous improvement.

The role requires a third-level science/engineering qualification and at least 5 years in a GMP QA environment, with strong collaboration across Quality, Manufacturing and Technical Services.

Qualifications

• 5+ years in a GMP QA environment.
• Experience reviewing batch records and investigations.
• Knowledge of change controls and process improvements.

Responsibilities

• QA ownership of Deviation Investigations, CAPA and audit support.
• Review/approval of Manufacturing Batch Records and QC testing.
• Approve production materials and provide QA guidance to Operations.
• Lead QA activities with cross-functional teams in the plant.
• Generate and approve SOPs and ensure GMP compliance.

Skills

QA

GMP

QMS

Documentation

English

Teamwork

Education

Third level qualification in science/engineering

Tools

Documentation systems

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.

Position Details

The QA Specialist will be responsible for delivery of QA activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will involve providing direct quality support to Operations at the facility.

The role will include the review and approval of batch related documentation and activities related to on-going manufacturing including the completion of root cause investigations of non-conformances, approving manufacturing related change controls and the implementation of process improvements.

This key role is an individual contributor role whereby the individual must be a self-starter with professional and academic experience in Quality Assurance. This key role must ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering and Technical Services.

This role will work on a permanent evening shift from 14:00 to 22:30pm.

Key Responsibilities

• QMS areas of responsibility include Deviation Investigations, Change Control and CAPA management systems; performing Internal Audits; assessing Customer Complaints; Vendor Management and supporting External audits
• Review /approval of Manufacturing Batch Records
• Assessment /approval of production materials including APIs, excipients, primary and secondary packaging
• QA point of contact for Operations providing technical expertise, feedback and guidance for QA and compliance topics /issues including manufacturing, validations, new product introduction and assist in the resolution of issues commensurate with the level of risk
• Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements
• Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility
• Review / approval of Quality Control testing
• Ensure schedules for review and approval of GMP /batch related documents are maintained to support batch release, technology transfers and new product introduction project timelines
• Ensure application of Quality Risk Management principles as applicable
• Act as the QA lead in QA activities in Operations work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others
• Actively contribute to continuous improvement activities
• Other duties as assigned

Job Specific Technical, Functional and Professional Competencies

• Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment
• In-depth knowledge of quality management system (QMS) procedures
• Strong understanding of GMP compliance and quality standards
• Strong Experience of using electronic and physical documentation systems
• Excellent attention to detail and significant document review experience essential
• Excellent technical writing skills including deviation investigation reports and SOPs
• Effective time management and multi-tasking skills
• Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
• Excellent communication skills, both verbal & written
• Proficient in written and spoken English
• Collaborative Team Player

Essential Education and Experience

• Third level qualification in relevant science and/or engineering discipline
• In-depth knowledge of Quality Management System (QMS) procedures
• 5 years minimum experience working in a GMP Quality environment
• Experience in a Quality function with strong knowledge of batch related documentation and activities related to on-going manufacturing including the completion of root cause investigations, change controls and the implementation of process improvements

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)