BMR560 | Quality Assurance Lead

26 lug - Medolla
Phibro Animal Health

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About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded,



global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.





If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you 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.

REPORTS TO

MFA / API Quality Operations Global Platform Lead

The Quality Assurance Lead / QP is responsible for ensuring quality, rigorously adhering to cGMP and Phibro standards. The Quality Assurance Lead will be responsible for overseeing the management of non-quality events, ensuring that qualification and validation processes meet regulatory and internal standards, and maintaining data integrity across all operations and projects. In addition,



he / she will play a crucial role in fostering a culture of continuous improvement and a quality mindset throughout the organization. This includes supporting the growth and development of team members, promoting collaboration across various functions, and driving initiatives to enhance processes and outcomes.

EDUCATION

Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy)

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

Coordinates and manage periodic audit with Regulatory and Health Authorities

Ensure that all SOPs and other related documents follow GMP and Phibro Quality Systems. He / she is 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 relative corrective actions

Manage customer complaints with related investigation, corrective activities, response and complaint closure

Coordinate the activities to support the management of supplier qualification and approve the 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 the general hygiene conditions of the premises and pest monitoring activities for which he / she is responsible

Provide information for, and complete,



as necessary customer by mail surveys, audits, and inquiries

As Qualified Person, the quality assurance lead is responsible to release each manufacturing batch according to D.Lgs 219 / 06 and register each batch in the site’s logbook for the 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 GMP’s through good quality programs, procedures, and training

Ability to prioritize different activities and manage multiple projects

Fluent in spoken and written English and Italian





To learn more about Phibro Animal Health's competitive benefits package, please click here : Phibro Benefits .

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

Department : Quality Assurance

Work Schedule : Monday - Friday (40 Hours)

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Pharmaceutical Manufacturing

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