Quality Specialist

Quality Specialist role at Thermo Fisher Scientific Overview Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) safety standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. Allowed in an office environment. Work Schedule Standard Office Hours (40/wk). Scope 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 Supervision : Continuously 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. Quality : Assist 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 aimed at removing 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. Procedures : Contribute to the creation and editing of procedures and processing sheets, verifying their usage in operations. Relationships Internal : QA/QC, Technology Transfer, Warehouses, All department heads, Engineering External : Suppliers of machinery and systems Requirements and Qualifications Essential: Diploma with validated experience or degree Knowledge of machinery, equipment, and methodologies for the production of drugs In-depth knowledge of GMP regulations Knowledge of the problems related to aseptic production Ability to use the main information systems Consolidated experience in QA/Production in pharmaceutical companies Languages: English Personal attributes: Tidiness, Observation skills, Relational skills, Critical thinking Desirable: Experience in manufacturing sterile injectable drugs and oral drugs Seniority level Not Applicable Employment type Full-time Job function Quality Assurance, Product Management, and Engineering Industries Pharmaceutical Manufacturing and Biotechnology Research J-18808-Ljbffr

Location: Monza, Lombardia, IT

Posted Date: 9/16/2025