Quality Assurance Lead & Qualified Person

About the Role

Profile Details Purpose -Assurance that the product quality conforms with specifications and that productionactivity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentationis up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP Major Accountabilities -Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs. -Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor
self-Inspection schemes for all sections. Monitor actions and corrections accordingly. -Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical
quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion. -Escalate any issues or instances of instability per the Novartis escalation policy and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure t
hat change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure. -Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs. -Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation. -Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products -Support launches of product in close collaboration with BD& L partner and/ or development organization. -Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations. -Ensure that coordinated contact is maintained with all part

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Role Requirements

Ideal Background Languages
English Experiences
Collaborating across boundaries
Functional Breadth
Operations Management and Execution
Participating in volunteer / community projects Competencies
Being resilient
Operational Excellence
Project Excellence Technical / Functional Skills & Knowledge
Product Release
Quality Assurance
Quality Change Control
Quality Management
Regulations & Guidelines
Risk Management