Summary The purpose of the investigation and deviation expert role is to work collaboratively with process experts and multifunctional operations teams in the Biologics and or large molecules platform sites taking ownership of deviation management for the site The individual will actively participate in investigations of deviations complaints and OOXs by interacting with Cross-Functional Teams CFT and implementing Corrective and Preventive Actions CAPA Effectiveness Checks EC risk assessments and quality management The role will play a key part in facilitating effective communication between teams and supporting problem- solving activities About the Role Major accountabilities Manage deviations in 1QEM system for the responsible sites using the Novartis quality management framework Conduct root cause analysis according to the established procedures and site practices Use various RCI Root Cause Investigations tools and methodologies such as Fishbone diagram 5 Whys and timeline and process mapping where applicable to facilitate root cause analysis Coordinate with the site SPOC Single Point of Contact and other stakeholders from the Production unit Quality Assurance Engineering team and site leadership team Ensure all stakeholders are informed about the progress of the investigation manage all necessary communications and adhere to timelines Participate and Facilitate Deviation and RCI review meetings capturing key information and translating it into actionable and clear documentation Track and report on metrics related to change control documentation including timeliness compliance and quality Develop revise and maintain high-quality documentation related to Deviation management processes ensuring alignment with cGMP and other regulatory standards Support and contribute to quality management system QMS actions such as Change Controls CAPA effectiveness checks EC risk assessments and OOXs management Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable Provide technical and scientific expertise to address process-specific matters ensuring compliance with cGMP SOPs and relevant guidelines and functional standards including HSE Health Safety and Environment and NOSSCE Ensure overall inspection readiness for the area of responsibility Support the creation and review of GxP documents including SOPs working procedures and trend reports while ensuring compliance with Novartis internal quality standards relevant regulatory requirements filed product quality standards and service level agreements Support Health Authority HA audits by ensuring compliance with the GxP workplace and handling procedural requirements in alignment with Quality Management System QMS standards Support implementation and adhere to all instructions and requirements for safe work environmental protection and property protection Comply with internal functional requirements such as KPI reporting ticket management tools and other internal procedures and processes Complete tasks determined during the annual objectives setting process and by KPIs as applicable Assist the team with any ad hoc activities or requests to meet business requirements Key Performance Indicators Quality Accuracy Right First Time Timeliness Deviations Escalations Quality System Management Change Control CAPA Risk Assessment and EC Support Specific Professional Competencies cGMP and Good Documentation Practices Deviation Handing Root Cause Analysis RCA Corrective Action and Preventive Action Change Control Management Knowledgeable on Effectiveness Checks Continuous Process Improvement Drug Substance Manufacturing Process Design and Control Gap Assessment and Risk Analysis Complaints and OOXs Handling Technology Transfer Report writing Data Analytics Project Management Languages English oral and written German at Least B1 level proficiency Experiences Minimum 6 years of experience in MS T Quality Assurance Regulatory or in the manufacturing of Biologics in large molecules At least 4 years of experience in MS T or Manufacturing operations Proficient knowledge on deviation handling incident investigations root cause analysis and CAPA management Knowledge of risk assessment and risk management programs Should be familiar with regulatory guidance on validation product filing and post approval changes Should be familiar with and able to perform basic statistical evaluations using tools like Minitab or Statistica with basic knowledge of statistical analysis result interpretation and usage of these tools Good communication presentation and interpersonal skills Why Novartis Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve this With our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us Learn more here https www novartis com about strategy people-and-culture You ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewards Commitment to Diversity and Inclusion Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve Join our Novartis Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here https talentnetwork novartis com network 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 Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Benefits and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Alternative Location 1 Ljubljana Slovenia Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve