Requirements: English
Company: TN Italy
Region: Medolla , Emilia-Romagna
Social network you want to login/join with:Position: MFA/API Quality Operations Global Platform LeadThe Quality Assurance Lead/QP is responsible for ensuring quality, rigorously adhering to cGMP and Phibro standards. The role involves overseeing non-quality events management, qualification and validation processes, and maintaining data integrity across operations. The Lead fosters a culture of continuous improvement, supports team development, promotes cross-functional collaboration, and drives process enhancements.EducationMaster''s degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy). Esame di stato is required.ExperienceMinimum 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.ResponsibilitiesMonitor production processes according to European and Phibro Quality Standards, EU directives, and regulations.Manage deviations, including generation, investigation, impact assessment, reporting, and approval.Review out-of-specification results and investigations from Quality Control.Ensure periodic reporting (Product Quality Review) and GMP self-inspections are conducted.Review quality acceptance criteria for raw materials, intermediates, and finished products.Coordinate audits with Regulatory and Health Authorities.Ensure SOPs and documents comply with GMP and Phibro Quality Systems; responsible for documentation control.Provide quality direction and manage changes for critical systems via change control procedures.Manage deviations and non-conformities, verifying corrective actions'' efficacy.Handle customer complaints, investigations, corrective actions, responses, and closure.Support supplier qualification and approve Quality Agreements as needed.Review and approve qualification/validation protocols and reports.Apply root cause analysis and Quality Risk Management methodologies.Supervise hygiene and pest monitoring activities.Contribute to customer surveys, audits, and inquiries.As Qualified Person, responsible for releasing batches per D.Lgs 219/06 and recording in the logbook.Core CompetenciesExcellent problem-solving and decision-making skills.Strong team-building and collaboration skills, both on-site and remotely.Promote continuous learning and development in quality.Enhance GMP understanding through programs, procedures, and training.Ability to prioritize activities and manage multiple projects.Fluent in spoken and written English and Italian.For more about Phibro Animal Health''s benefits, please click here.#J-18808-Ljbffr