Jefferson Wells is looking for a Quality Assurance Operations Manager on behalf of an Italian pharma company. The candidate manages Good Manufacturing Practices (GMP) compliance with production site operations. He/she manages data collection and information related to each batch and reviews the relevant documentation. Furthermore, he/she is responsible for carrying out investigations, managing quality issues resolutions, and activities related to Product Quality Review and Complaints. He/She manages the activities and data collection needed for the revision of the Quality System and the Quality Management Review. Main Tasks: Manages and coordinates Batch Record Review activities. Reviews production and analysis documentation and provides judgment for batch release evaluation by Qualified Person. Promotes, coordinates, carries out and documents appropriate investigations in case of deviations from validated processes, procedures, working instructions, acceptance criteria and/or filed documentation. Manages labs issues (e.g. OOS, OOT) related to semi-finished and finished products, in collaboration with Quality Control. Manages periodic monitoring (trend analysis) of variances related to semi-finished and finished products. Manages and coordinates corrective and preventive actions and their implementation. Assures availability of Product Quality Reviews annual plan, data collection and reports issue. Manages and coordinates activities related to customer complaints (e.g. investigations, reports, registrations), in collaboration with other concerned Company functions, up to customer feedback and CAPA implementation. Supports implementation of GMP training program for personnel involved in drugs production and control. Collects and processes data related to key quality performance indicators (e.g. number of deviations, right first time, corrective actions progress status). Main Requirements: Bachelor's/Master's Degree in Biotechnology, Biology, Pharmacy, Chemistry or related scientific field; 10 years of experience in Quality area in the Pharmaceutical/Life-science sector. Technical Expertise: Knowledge of national and international pharmaceutical and GxP regulations; Knowledge of the Pharmaceutical sector (Production, Quality Control, Engineering, Industrial Development processes); Languages: Italian and English (fluent); Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office); Knowledge of Project Management principles. J-18808-Ljbffr