Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. The QA Manager/RP will be responsible 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.
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
~ 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
~ 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
~ Keep up to date with changes/ updates in legislation via Health Authority websites and/or newsletters, and any directive regulations or guidelines
~ Proven Experience in the pharmaceutical industry, GxP knowledge preferably in a matrix organisation.
Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
Development of quality systems and/or processes
Good level of skills in the use of computer based systems and applications
Knowledge of products traded under the license and access to pharmaceutical knowledge and advice when it is required
Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:
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