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.
