QA Specialist (Validation)

at  Phibro Animal Health Corporation

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 (Validation) is an integral part of our Quality Assurance team based out of our Ireland - Sligo site.

EDUCATION /EXPERIENCE

• Third level qualification in relevant science and/or engineering discipline
• 5 years minimum experience working in a in a GMP Quality environment providing QA technical support and oversight to validation and qualification activities
• Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations

• Site 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.
• 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.
• 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 investigations, Change Control and CAPA management systems; Internal/External audits; 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.
• 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 including the application of risk assessment tools such as FMEA
• 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.