Summary

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

About the Role

Common Accountabilities: (Applicable to all services in QOP)

• Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes
• Assist the department on any other ad hoc activities/ requests to meet the business requirements
• Regularly communicate with partners and obtain feedback on services delivered
• Focus on timely completion of all relevant and assigned trainings
• Learn & develop understanding to generate insights through data and digital
• Ensure responsibility and ownership of the assigned tasks
• Comply with accuracy and timeliness of deliverables
• Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements
• 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 by collecting and presenting the requested process/ data and reports
• Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
• Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables
• Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
• Assist the department on any other ad hoc administrative activities as per business requirements
• Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable

• Manage different types of change control like product stewardship/Administration Stewardship/Asset Stewardship in electronic systems like Agile from Change Initiation to closure as needed
• Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions as required.
• Perform Regulatory assessment on Change Controls as needed.
• Perform deviation investigations and CAPAs as part of change management.

• M. Pharm/ MBA / Engineering/equivalent from a reputed institute.
• Min 6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device.
• GMP -knowledge, Broad IT-knowledge
• Fluent in English (written and spoken)
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders

• English