Summary

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QSC and business partners. Manage Quality aspects & projects within area of responsibility.

About the Role

Key Responsibilities:

• 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, etc.) to ensure appropriate execution of service deliverables

• Generate and analyze predefined and ad-hoc reports in various applications (like 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.

• Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.

• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes.

• Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable.

• 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 the accuracy and timeliness of deliverables

• Comply to the applicable Novartis operating procedures as per legal / IT / HR requirement

• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations.

• Lead / transition new service or expansion projects, monitor and report progress and deviations, as appropriate.

• Adherence to the service KPI's and ensuring the service dashboard, order management framework and time sheet is always kept updated.

• Train, develop or mentor personnel for successful and timely onboarding in Quality Operations

• Provide active support during internal and external audits by collecting and presenting the requested process data/reports

• Hold accounts and develop understanding on trouble shooting in workflow applications (such as SAP, Dragon, SUBWAY, etc.)

• M.Pharm/ MBA / Engineering/equivalent from a reputed institute

• Min 6 Yrs experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device, expertise in LMS

• GxP-knowledge, Broad IT-knowledge, Proficient in MS-Office

• Excellent communication, presentation and interpersonal and analytical skills

• Experience of working closely with the global stakeholders.

• Project Management skills