Job Description
Quality Assurance Specialist (Validation) sought to ensure product manufacturing meets GMP and regulatory requirements, with a focus on validation and qualification activities.
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.
Job Description
The QA Specialist (Validation) is an integral part of our Quality Assurance team based out of our Ireland site. The role will be responsible for the delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements.
- 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.
- 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.
- 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, multi-department teams.
- Actively contribute to continuous improvement activities.
Requirements
- Third level qualification in relevant science and/or engineering discipline.
- 5 years minimum experience working 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 c GMP Regulations.
- Core Competences: Strong understanding of GMP compliance and quality standards, in-depth knowledge of quality management system (QMS) procedures and technical documentation.
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.