Microbiologic Technician

Description

Summary: This role supports all GxP activities within the Quality department, manages quality systems and processes, and ensures compliance with Novartis Quality Standards. Highlights: 1. Supports GxP activities and quality management within the organization 2. Manages quality systems, documentation, and action monitoring 3. Performs routine GxP Compliance/Operational activities ### **Summary** \~Supports all GxP activities within the Quality department. Manages quality systems / processes, including documentation, statistics, and action monitoring. \~Supports the establishment of high-quality operational processes. Performs routine GxP Compliance/Operational activities in accordance with Novartis Quality Standards. Supports quality projects and \-initiatives. ### **About the Role** Major Accountabilities \~Maintains applicable Standard Operating Procedures (SOPs), GxP-compliant documentation and records within the Novartis Quality Management System. \~Ensures the integrity of all Quality Systems records and data, where applicable, and collaborates across own team and with other functions and departments. \~Ensures adequate training level and GxP knowledge. \~Updates and maintains relevant information in electronic systems (e.g., Change Control, Documentation, Training). \~Follow-up and monitoring of, for example, GCAs, actions, statistics, Quality Plan). \~Supports quality audits and inspections by Health Authorities. \~Reports technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. \~Distribution of samples for product launch (if applicable) Key Performance Indicators \~Supports all GxP activities within the Quality department. Manages quality systems / processes, including documentation, statistics and action monitoring. \~Supports the establishment of high-quality operational processes. Performs routine GxP Compliance/Operational activities in accordance with Novartis Quality Standards. Supports quality projects and \-initiatives. Work Experience \~QC/QA in pharmaceutical industry / biotech with environmental monitoring \& cleanroom zones \~Functional depth \~Cross-border collaboration Skills \~Technological intelligence \~QA (Quality Assurance) \~GMP procedures \~Quality standards \~Quality Control (QC) testing \~Dealing with ambiguity \~Self-awareness \~Continuous learning \~Technological expertise Language English **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Division Operations Business Unit Quality Location Spain Site Zaragoza Company / Legal Entity ES45 (FCRS \= ES045\) AAA Ibérica S.L.U. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No VIDEO