Quality Associate Analyst

Job description

Contract Provider : Associate Analyst – Quality Operations : Randstad India Private Ltd. Department : Quality Operations Partner Reporting Manager title : Team Lead – Quality Operations Entry date in new role : DD-MMM-YYYY Job Purpose Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility. Major Accountabilities Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Assist the department with any other ad hoc activities/ requests to meet the business requirements. Focus on timely completion of all relevant and assigned trainings. Learn, develop & leverage data and digital tools to build understanding and generate insights that support quality operations and decision-making as needed. Ensure responsibility and ownership of the assigned tasks and comply with accuracy and timeliness of deliverables. Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements 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 in support of product quality compliance and regulatory workflows. Hold accounts in workflow applications to ensure appropriate execution of process deliverables, using approved enterprise platforms as applicable. Escalate process 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 and any filed product quality standards. Engage regularly with business partners to gather feedback on the support provided and deliverables, ensuring continuous improvement and alignment with operational needs. Support the Master Data Management to the required sites as needed. Manage various types of change controls (e.g., Product, Asset, and others) using Novartis-approved digital platforms from initiation to closure, as applicable. Generate and analyze predefined and ad-hoc reports using authorized enterprise applications and perform follow-up actions as needed. Perform designated roles such as Entity Data Manager, Business Approver, P31 Module Approver, CRB Facilitator, Key User, and NCQ Non-Duplication Activity, based on business requirements. Provide governance support as needed. Job Dimensions (Indicate key facts and figures) Number of Associates: NA Direct: NA Financial responsibility: NA Indirect: NA Page 2 Ideal Background / Requirements for the role • M. Pharm/ MBA / Engineering/equivalent from a reputed institute • Common requirements for experienced associates • Min. 0-2 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances /products/Medical device • Basic computer skills