Quality Assurance Medolla

Quality Assurance
Medolla
Emilia Romagna, Medolla

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.

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.

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

**Position Details**:

- EDUCATION

- Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Pharmacy or equivalent)

EXPERIENCE

- Minimum of 5 years' experience in a similar role, ideally in a pharmaceutical manufacturing facility, with at least 2 years' experience in a managerial role

- Strong knowledge of GMP regulations and quality management systems

- Experience with regulatory, client and self-inspections audits.

- Strong analytical and problem-solving abilities

- Eligible for Qualified Person role

- Fluent in spoken and written English and Italian

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 (QC) 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.

- In-depth knowledge of GMP regulations and pharmaceutical production processes.

- Good team building and collaboration while working on teams.

- Generate a culture of continuous learning and development for the site quality organization and provide the site with continuous development of understanding of GMP's through good quality programs, procedures, and training.

- Ability to prioritize different activities and manage multiple projects.

- Good communication skills.

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

**Division: Animal Health & Nutrition

**Department: Quality Assurance

**Location: Medolla, Italy

**Work Schedule: Monday - Friday (40 Hours)