Quality Specialist

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Descrizione impiegoSCOPE OF THE POSITION/RESPONSIBILITIES:Assure that the pharmaceutical production of sterile injectables follows current regulations (US and EU GMP) and company quality standards via prevention, constant control, and improvement interventions.SPECIFIC TASKS/PRIMARY ACTIVITIES:SupervisionContinuously lead all aspects of the production lines of sterile forms (cleaning, mix-up, operation, defects) to ensure that all processes adhere to the latest regulations and maintain the quality standards of the company.QualityAssist in coordinating and leading all aspects of machinery testing and validation tasks, ensuring compliance with existing regulations and the quality criteria set by the company.Participate in the execution of self-audits and in the implementation of any corrective actions in compliance with current regulations and company quality standards.Participate in the analysis and definition of actions striven to remove the causes of defects and complaints.Based on the results of controls and monitoring, propose GMP training courses suitable for production activities and take part in them as a trainer.ProceduresContribute to the creation and editing of procedures and processing sheets, verifying their usage in operations.RELATIONSHIPS:INTERNALQA/QCTechnology TransferWarehousesAll department headsEngineeringEXTERNALSuppliers of machinery and systemsREQUIREMENTS AND QUALIFICATIONS: Essential:Studies/Diplomas/Training courses:Diploma with validated experience or degreeTechnical and IT knowledge:Knowledge of machinery, equipment, and methodologies for the production of drugsIn-depth knowledge of GMP regulationsKnowledge of the problems related to aseptic productionAbility to use the main information systemsProfessional experience:Consolidated experience in QA/Production in pharmaceutical companiesLanguages:EnglishPersonality traits:TidinessObservation skillsRelational skillsCritical thinking Desirable:Experience in manufacturing sterile injectable drugs and oral drugs