Job Summary: A professional responsible for defining requirements, executing, and managing qualification and validation activities for systems and equipment in the sterile area, ensuring regulatory compliance. Key Highlights: 1. Experience in qualification and validation in the pharmaceutical industry. 2. Ensures process compliance with GMP regulatory standards. 3. Develops and applies expertise in the sterile area. Ref. 1327 \- and your Curriculum Vitae (CV) to **recrutamento@bluepharma.pt**. #### **Key Responsibilities** * Define requirements for manufacturing equipment and critical infrastructure in the sterile area; * Execute and manage qualification and validation activities for systems, equipment, and infrastructure; * Ensure process and system compliance with regulatory standards regarding cross-contamination prevention, cleaning validation, calibration, and qualification of manufacturing equipment and critical infrastructure such as water systems, HVAC, compressed air, and gases; * Plan, develop protocols, execute, evaluate, and report on activities within the area; * Develop and apply expertise to the sterile area. #### **Requirements** * Higher education degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related field; * Solid knowledge of GMP standards applicable to sterile manufacturing; * Prior experience in qualification and validation (in the pharmaceutical industry); * Advanced proficiency in English; * Strong analytical, planning, and organizational skills; * Team spirit, proactivity, and sense of responsibility; * Good communication skills and ability to prepare technical reports.
João Santos
Indeed · HR
João Santos
Indeed · HR
