QA Manager and QP

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The purpose of the role is: To perform duties of the Qualified Person in compliance with all applicable GMP regulations and directives. Provide leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation meeting internal and external stakeholder requirements. Streamline and improve quality processes, facilitate quality management and lead the development of a right first time, quality culture. Your Key Responsibilities: Your responsibilities include, but not limited to: Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local workpractices, Responsibility for monitoring compliance of the quality activities/systems owned locally – including metrics, quality review and self-inspection. Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence. Perform routine risk/impact evaluations associated with product based decisions or the quality system and participate in escalation situations Ensure local compliance with global standards/SOP’s and maintain relevant local SOP’s. Communicate requirements and/or changes and act as content expert for audits and inspections using knowledge of associated systems Investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation (where necessary in conjunction with nominated third parties) to minimise impact on product availability and sales Gain expert knowledge of IT platforms/applications supporting quality systems and be able to act in multiple roles within that system as applicable Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Global QA organization and vice-versa including but not limited to issue escalation Develop and recommend changes for productivity and quality improvements. Lead in implementation of quality initiatives