About Phibro Animal Health CorporationPhibro 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.The Quality Assurance Lead is an integral part of our Quality Assurance team based out of our Medolla, Italy site.REPORTS TOMFA/API Quality Operations Global Platform LeadThe 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.EDUCATIONMaster's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy)EXPERIENCEMinimum of 5 years’ experience in a similar roleStrong knowledge of GMP regulations and quality management systemsExperience with regulatory, client and self-inspections auditsEligible for Qualified Person roleRESPONSIBILITIESEnsure effective monitoring of production processes according to European and Phibro Quality Standards and EU directives and regulationsManage deviations (generation, investigation, impact, reporting and approval)Review of Quality Control out of specification results and investigationsEnsure the execution of periodic report (Product Quality Review) on the manufactured products and the GMP self-inspectionReview of quality acceptance criteria for raw materials, intermediates products, and finished productsCoordinates and manage periodic audit with Regulatory and Health AuthoritiesEnsure that all SOPs and other related documents follow GMP and Phibro Quality Systems. He/she is responsible for site GMP documentation controlProvide quality direction and manage the implementation of changes for critical company systems, according to the "change control" procedureManage deviations and non-conformities, ensuring the quality of the finished product and verifying the efficacy of the relative corrective actionsManage customer complaints with related investigation, corrective activities, response and complaint closureCoordinate the activities to support the management of supplier qualification and approve the related Quality Agreement (where necessary)Review and approve qualification/validation protocols and reportsKnowledge of root cause analysis methodology and Quality Risk ManagementCollaborates in the supervision of the general hygiene conditions of the premises and pest monitoring activities for which he/she is responsibleProvide information for, and complete, as necessary customer by mail surveys, audits, and inquiriesAs 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 inspectionCORE COMPETENCIESExcellent problem-solving and decision-making skillsGood team building and collaboration both on-site and with teams remotelyPromote a culture of continuous learning and development for the site quality organizationImprove on-site understanding of GMP’s through good quality programs, procedures, and trainingAbility to prioritize different activities and manage multiple projectsFluent in spoken and written English and ItalianPhibro is an Equal Opportunity EmployerAll 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 NutritionDivision: Animal Health NutritionDepartment: Quality AssuranceLocation: Medolla, ItalyWork Schedule: Monday - Friday (40 Hours)
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