Specialist-Quality Operation

Major accountabilities:

• Exposure in handling of customer/market complaints, field alerts, recalls and conducting investigations. Can independently handle meetings/ discussion with business partners/ suppliers.
• Experience in creating Quality assurance agreement and Quality risk assessment for Contract manufacturers / suppliers.
• Understanding on Audits & CAPA management for suppliers.
• Strong understanding on Quality Management System and GxP requirements.
• Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP s, Investigation reports, etc., where required.
• Ensure implementation of applicable Novartis QMS requirements in the function.
• Provide support as key user/ Super user for IT tools used for Quality Management System.
• Provide timely and effective communication of any potential compliance gaps/ risks in respective function, the respective SPOCs or Team Lead and facilitate for resolution of identified gaps/ risks.
• Initiate, monitor and fulfill the timely review of APQR documents for all own site and Contract manufacturers.
• Provide quality support to Nitrosamine risk-based evaluation/ Changes, as required. Initiate and implement quality improvement/ simplification projects, wherever possible. Impart trainings on GMP/Data integrity and other relevant trainings, as required.
• Create various periodic performance metrics reports for respective GxP activities and share/ present to Business leaders/ partners.
• Author technical documents (like testing plans, testing monographs, Stability report etc.) and provide data driven technical and analytical insights to improve process understanding, quality and compliance of the product.
• Manage different type of change control like product stewardship/ Administration Stewardship /Asset Stewardship in electronic system like Agile PLM, from Change Initiation to closure as needed.
• Experience in Document Management tools and competency in MS office tools.
• Ensure all time readiness of the activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs.