Job Description Summary
At Sandoz, our Purpose is pioneering access for patients
Job Description
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 & continuous improvements including project planning, milestone delivery and communication within the team and cross functionally.
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 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.
Support and development of personnel in Sandoz Quality team using Capability Assessment and MyGrowth tools
Resource planning with the team with responsibility to ensure personnel are trained to undertake GxP activities
To conduct batch assessment and release activities, in a timely manner, and meeting relevant regulatory standards
To lead activities supporting batch release, ensuring oversight of the Quality System and carrying out tasks such as QP declarations and review of APQR’s.
Perform agreed communications with MHRA
Maintain knowledge in accordance with the Qualified Person’s Code of Practice
Support and development of personnel in Sandoz Quality team using Capability Assessment and MyGrowth tools
Resource…