Medicina · Medolla, Emilia-Romagna, It · · 70.000€ - 110.000€


Descrizione dell'offerta

The Quality Assurance Supervisor

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 2,400 employees worldwide. TheQuality Assurance Supervisoris an integral part of our Quality Assuranceteam based out of our Medolla, Italysite. Qualifications

Master's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy) Esame di stato is required Minimum of 5 years’ experience in a similar role, ideally in a pharmaceutical manufacturing facility 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 Ensure the execution of periodic report (Product Quality Review) on the manufactured products and the GMP self-inspection Manage deviations (generation, investigation, impact, reporting and approval) Review of Quality Control (QC) out of specification results and investigations 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 ensure compliance with Regulation (EU) 2019/6 on veterinary medicinal products, applicable EU GMP requirements, marketing authorizations, manufacturing authorizations, and relevant national implementing legislation. Provide quality oversight of feed additive manufacturing activities and ensure compliance with applicable feed and feed-additive regulations, site licenses, and quality standards. Ensure appropriate segregation between veterinary medicinal product GMP activities and feed additive quality requirements where applicable. 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 Strong communication skills Fluent in spoken and written English and Italian 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)

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