QA Officer Operations

Description

Summary: Manages quality aspects and projects within the area of responsibility, ensures and supports overall GxP compliance and compliance with Novartis Quality Management Systems. Highlights: 1. Ensures and supports GxP compliance 2. Supports exception investigations 3. Quality Assurance and GMP Procedures ### **Summary** \~ Manages quality aspects and projects within the area of responsibility. \~ Ensures and supports overall GxP compliance and compliance with Novartis Quality Management Systems. ### **About the Role** Major Accountabilities \~ Ensures cGxP compliance for all manufacturing and testing activities, including data integrity and e-compliance \~ Supports exception investigations \~ Reviews and approves manufacturing, QC, and AS&T records \~ MBR inc. \~ Supports OpEx improvement projects Qualified Person \- Executes batch release in accordance with regulatory requirements \~ Reports technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \~ Distribution of marketing samples (where applicable) Key Performance Indicators \~ Manages quality aspects and projects within the area of responsibility. \~ Ensures and supports overall GxP compliance and compliance with Novartis Quality Management Systems. Work Experience \~ Environmental monitoring and cleanroom areas, and QC/QA in pharmaceutical industry / biotechnology \~ Functional scope \~ Cross-border collaboration Skills \~ Technological Intelligence \~ QA (Quality Assurance) \~ GMP Procedures \~ Quality Standards \~ Quality Control (QC) Testing \~ Dealing with Uncertainty \~ 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 Production / Manufacturing Location Spain Site Zaragoza Company / Legal Entity ES45 (FCRS \= ES045\) Advanced Accelerator Applications Iberica S.L.U. Functional Area Quality Job Type Full time Employment Type Permanent Shift Work No VIDEO