Quality Assurance Lead

Overview

Join to apply for the Quality Assurance Lead role at Phibro Animal Health Southeast Asia

About Phibro Animal Health Corporation: Phibro is a publicly traded, global organization with a history in animal health and nutrition, manufacturing and marketing medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. The company supports livestock producers, farmers, veterinarians, and consumers by providing solutions to maintain and enhance animal health. Phibro is a diversified company with revenues over $1 billion and more than 2,300 employees worldwide. The organization emphasizes a diverse workforce and a culture that encourages creativity and skills development. If you feel you do not meet all qualifications, you are encouraged to apply as you might be the right candidate for this role or other positions.

The Quality Assurance Lead is an integral part of our Quality Assurance team based out of our Medolla, Italy site.

Position Details

Reportsto MFA/API Quality Operations Global Platform Lead

The Quality Assurance Lead/QP is responsible for ensuring quality, rigorously adhering to cGMP and Phibro standards. This role oversees the management of non-quality events, ensures qualification and validation processes meet regulatory and internal standards, and maintains data integrity across all operations and projects. The role also fosters a culture of continuous improvement and a quality mindset, supports growth and development of team members, promotes cross-functional collaboration, and drives initiatives to enhance processes and outcomes.

Education

Education
Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy)
Esame di stato is required

Experience

• Minimum of 5 years’ experience in a similar role
• Strong knowledge of GMP regulations and quality management systems
• Experience with regulatory, client and self-inspections audits
• Eligible for Qualified Person role

Responsibilities

• Ensure effective monitoring of production processes according to European and Phibro Quality Standards and EU directives and regulations
• Manage deviations (generation, investigation, impact, reporting and approval)
• Review of Quality Control out of specification results and investigations
• Ensure the execution of periodic report (Product Quality Review) on the manufactured products and the GMP self-inspection
• Review of quality acceptance criteria for raw materials, intermediates, products, and finished products
• Coordinate and manage periodic audits with Regulatory and Health Authorities
• Ensure that all SOPs and related documents follow GMP and Phibro Quality Systems; responsible for site GMP documentation control
• Provide quality direction and manage the implementation of changes for critical company systems, according to the "change control" procedure
• Manage deviations and non-conformities, ensuring the quality of the finished product and verifying the efficacy of the related corrective actions
• Manage customer complaints with related investigation, corrective activities, response and complaint closure
• Coordinate activities to support management of supplier qualification and approve related Quality Agreement (where necessary)
• Review and approve qualification/validation protocols and reports
• Knowledge of root cause analysis methodology and Quality Risk Management
• Collaborates in the supervision of general hygiene conditions of the premises and pest monitoring activities
• Provide information for, and complete as necessary customer by mail surveys, audits, and inquiries
• As Qualified Person, release each manufacturing batch according to D.Lgs 219/06 and register each batch in the site’s logbook for regulatory inspection

Core Competencies

• Excellent problem-solving and decision-making skills
• Good team building and collaboration both on-site and with teams remotely
• Promote a culture of continuous learning and development for the site quality organization
• Improve on-site understanding of GMPs through quality programs, procedures, and training
• Ability to prioritize different activities and manage multiple projects
• Fluent in spoken and written English and Italian

Equal Opportunity

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.

Location: Medolla, Emilia-Romagna, Italy • Work Schedule: Monday - Friday (40 Hours)

Industry: Pharmaceutical Manufacturing