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 (Operations) is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.
POSITION SUMMARY
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 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 ongoing 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.
PRINCIPLE 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 SOPs/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, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.Actively contribute to continuous improvement activities.Other duties as assigned.EDUCATION / 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 ongoing 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 (Standard Work hours) Weekly Working Hours: 40.00
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