摘要
-Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions.
-Supports establishment of Quality operational processes.
-Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives.
About the Role
• Adhere to internal operational requirements such as KPI (Key Performance Indicators) reporting, managing tickets, and following other internal processes and procedures
• Engage in any special tasks or activities needed to fulfil business requirements
• Accuracy in using computer systems, software, and applications related to quality management such as SAP, MS Office, etc.
• Produce and interpret predefined and customized reports in various systems GxP compliant electronic systems (like AGILE PLM, AQWA etc.) and carry out necessary follow-up actions.
• Regularly interact with partners, soliciting feedback on common objectives and deliverables
• Learn and enhance understanding to create data-driven insights
• Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements
• Understanding of QMS including documentation, regulatory requirements, audits, and process improvement.
• Awareness of regulatory affairs and guidelines related to the pharmaceutical industry such as FDA regulations, GMP, GLP, and ICH guidelines.
• Oversee quality compliance, including APQR plans, SharePoint updates, QAA (Quality Assurance Agreement), audit CAPA management, documentation handling, and supplier record management.
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
• Provide active support during internal and external audits
• Identify areas for process improvement, find solutions, and address quality-related problems efficiently.
• Compliantly manage the in-scope training matrix.
• Define system setup and coordinate learning management system maintenance with administrators.
• Handle all in-scope reporting requirements.
• Communicate the availability of learning content to support NTO associates' curiosity and growth.
• Manage local learning events for NTO Operations Hubs and support events at in-scope sites.
• Apply solid instructional design methodology, incorporating adult learning theory, interactive activities, and competency-based evaluations.
• Create engaging learning activities and compelling course content to enhance retention and transfer.
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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.
