Job Description Summary
-Supports all GxP activities in the Quality department.
Job Description
• 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.
•Top of Form
Skills Desired
Collaboration, Communication Skills, Data Integrity, Deadline Adherence, Dealing With Ambiguity, Digital saviness, Health & Safety Regulations Knowledge, Leadership, monitoring, Problem Solving Skills, Punctuality, Regulatory Requirements knowledge