Associate Manager - Quality Operations

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.) 

Essential Requirements:

• 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