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CPO GMP Quality Manager

9 minutes ago

Singapur, Singapore Novartis Singapore Full time

Overview Assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date, archived correctly, and maintain state‑of‑the‑art GxP know‑how and future trends in the field of GxP. Key Responsibilities Ensure compliance of handling, manufacturing and distribution of biopharmaceutical/ pharmaceutical products with the Novartis Quality Manual, Quality Agreements, relevant GxP regulatory requirements and local SOPs. Prepare, review and check batch documentation for correctness, completeness; archive original documents for the prescribed period and conduct self‑inspection schemes for all sections. Monitor actions and corrections and conduct GxP monitoring on all sections; investigate non‑compliance, follow up corrective actions. Archive relative documentation and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits, product tampering, stability failures) according to the Quality Agreement and Novartis Quality Manual. Ensure investigations are correctly executed; decide escalation to senior management, lead global quality assessments and manage filing accordingly. Manage change requests according to Novartis SOPs from receipt to implementation and closure. Assess quality trends, drive continuous improvement for processes and product quality performance and maintain regulatory access as required. Identify repetitive activities and regulatory areas for SOP development; introduce SOPs. Plan, initiate and monitor basic GxP‑training for all employees at regular intervals. Essential Requirements Participating in volunteer / community projects. Functional Breadth. Collaborating across boundaries. Operations Management and Execution. Skills Change Control. Continuous Learning. Dealing With Ambiguity. Guideline. Product Release. Qa (Quality Assurance). Quality Management. Regulation. Risk Management. Self Awareness. Technological Expertise. Languages English. Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: #J-18808-Ljbffr