QA Specialist

T-pro; Sligo; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading global animal health company in Sligo is seeking a QA Specialist to ensure compliance with GMP and regulatory requirements. The ideal candidate will have at least 5 years of experience in a GMP Quality environment. Responsibilities include managing the Quality Management System, approving documentation, and leading QA activities across departments. This is a full-time position within the Pharmaceutical Manufacturing industry.

Qualifications

• Minimum 5 years experience in a GMP Quality environment.
• Strong knowledge of Project Life Cycle and cGMP Regulations.
• Experience in a Validation function.

Responsibilities

• Act as the QA point of contact for compliance topics.
• Manage assigned areas of Quality Management System.
• Generate, review, and approve SOPs and other documentation.
• Perform timely reviews of site procedures to ensure compliance.
• Act as the QA lead in cross-functional project activities.

Skills

GMP compliance

Technical writing

Attention to detail

Time management

Troubleshooting skills

English proficiency

Education

Third level qualification in relevant science or engineering

Job description

Overview

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.

Job Purpose

The QA Specialist will be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will also include the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.

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

Key Responsibilities

• QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing 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.
• QMS areas of responsibility include Deviation, Change Control and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
• Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
• Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
• Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.
• Ensure schedules for review and approval of GMP /validation documents are maintained to support 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 project 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

• Strong understanding of GMP compliance and quality standards
• Excellent attention to detail and significant document review experience essential
• Excellent technical writing skills including deviation 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
• Proficient in written and spoken English

Essential Education and Experience

• Third level qualification in relevant science and/or engineering discipline
• 5 years minimum experience working in a GMP Quality environment.
• Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations.

To learn more about Phibro Animal Health's competitive benefits package, please see Phibro Benefits.

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

Department: Quality Assurance

Location: Ireland - Sligo

Work Schedule: Monday - Friday (39 Hours)

Details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing