About Phibro Animal Health Corporation Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, vaccines, and specialty chemicals for various industrial markets. Phibro's revenues are in excess of $820 million and are supported by over 1500 employees worldwide.
The QA Specialist is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.
POSITION SUMMARYThe 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 ongoing 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.
PRINCIPLE RESPONSIBILITIESSite 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, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.Actively contribute to continuous improvement activities.Other duties as assigned.EDUCATION / EXPERIENCEThird 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.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 (Standard Work hours) Weekly Working Hours: 40.00
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