Overview Purpose : 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. Responsibilities 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. Assure 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). Supports Quality functions and Qualified Person in GMP inspections from AIFA, FDA, Customers, Certification Bodies, Foreign Affairs Ministries management. Assists Quality System in self-inspections plan and audits to suppliers and Third Parties. Supports Pharma QA & QP Associate Director in definition, allocation and management of Department projects / initiatives budget. Monitors compliance with legal, ethical, and company norms by directly or indirectly supervised individuals Acts as "Preposto" according to d D. Lgs. 81 / 2008 Ensures compliance with laws and regulations in accordance with the provisions of the internal control model, D. Lgs. 231 / 01 and codes of conduct within the area of responsibility J-18808-Ljbffr