Lead, Qualified Person
2 weeks ago
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• 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.
• To perform duties of the Qualified Person in compliance with all applicable GMP regulations and directives.
• To perform the duties of a Responsible Person for Import (RPi) ensuring a system to confirm that the required QP certification is in place for all products imported into Great Britain
• Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local work practices.
• 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
• 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 the impact on product availability and sales
• Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management
• Work with the country organisation business franchises/brands to provide direction and support for all quality / GMP matters. Provide GxP education and training to others in the team and across the CO.
• Act as a role model for Sandoz Values and Leadership Behaviours, taking positive action to strengthen quality culture and awareness
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