Quality Assurance Manager

LHH Per a pharmaceutical company client based in Milan, we are currently looking for a Quality Assurance Manager COMPITI E RESPONSABILITÀ PRINCIPALI - Coordinates the infrastructure and services involved to ensure that the Quality System is constantly efficient, controlled, and documented - Ensures that an active quality management system is established and maintained - Keeps the Qualified Person and General Management informed about activities performed and any problems or deviations - Ensures that all production activities are carried out in accordance with cGMPs verifies the state of validation of all equipment, instruments, and systems, as well as all processes and analytical methods - Ensures that all personnel is suitable for their job position and maintains a system of training and education punctual and effective - Defines, organizes, supervises, and manages procedures and operational activities for quality within the policies and strategies defined - Approves all procedures, analytical methods, specifications, MBRs, and PQS documentation - Ensures that all documentation is managed and archived properly - Approves validation protocols and reports - Approves the Site Validation Master Plan and Validation Plans - Registers all complaints, ensures a thorough investigation, and sends the results within the times set by MAH - Prepares the Director's Review Report and organizes periodic meetings with the Director - Ensures that statistical reports on quality are prepared for various processes using appropriate statistical techniques - Ensures that a preventive maintenance program and plant metrology is in place - Examines and approves documentation for each production batch, verifying its coherence and completeness - Receives data from the market to define and optimize quality standards based on emerging needs - Conducts risk analysis studies. Holds training sessions as a trainer - Stays updated on specific topics, cGMPs, and norms, disseminating information within the Department - Ensures an information system suitable for evaluating and constantly controlling the trend of quality - Reports on System performance and any need for continuous improvement to enable review - Guarantees that all Organization has awareness of customer requirements - Contributes, in the context of preventive quality improvement, to setting up new facilities and optimizing maintenance and logistics procedures - Assists General Management in the planning and implementation phase of projects - Collaborates with clients, regulatory authorities, and certifying bodies - Is responsible, within its activities, for respecting safety, health, and environmental prescriptions - Keeps professional knowledge and experience updated through meetings and external courses Your Profile SPECIFIC COMPETENCES REQUIRED - Knowledge of GMP and ISO norms - Knowledge of norms/directives for equipment and/or system validation - Knowledge of microbiology and hygiene, GMP for sterile product production and asepsis - Knowledge of gowning and behavior for conducting a cleanroom - Knowledge of regulatory requirements regarding media fill and competence in their management - Competence in writing, managing, reviewing analysis documentation - Competence in managing Out-of-Specification (OOS) - Competence in managing ICH Stability and ongoing - Knowledge of Change Control - Knowledge of the English language Completes the profile flexibility and availability for complete collaboration with other department functions. #LI-ML2 Sector: Pharmaceutical industry Role: Other