OverviewJoin to apply for the Quality Assurance Lead role at Phibro Animal Health Southeast AsiaAbout 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 DetailsReportsto MFA/API Quality Operations Global Platform LeadThe 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.EducationEducationMaster's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy)Esame di stato is requiredExperienceMinimum 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 productsCoordinate and manage periodic audits with Regulatory and Health AuthoritiesEnsure that all SOPs and related documents follow GMP and Phibro Quality Systems; 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 related corrective actionsManage customer complaints with related investigation, corrective activities, response and complaint closureCoordinate activities to support management of supplier qualification and approve 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 general hygiene conditions of the premises and pest monitoring activitiesProvide information for, and complete as necessary customer by mail surveys, audits, and inquiriesAs Qualified Person, release each manufacturing batch according to D.Lgs 219/06 and register each batch in the site’s logbook for 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 GMPs through quality programs, procedures, and trainingAbility to prioritize different activities and manage multiple projectsFluent in spoken and written English and ItalianEqual OpportunityPhibro 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.Location: Medolla, Emilia-Romagna, Italy • Work Schedule: Monday - Friday (40 Hours)Industry: Pharmaceutical Manufacturing
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