At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:
Finding the right balance between guaranteed quality, reliable supply, and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality. We are committed to protecting our environment (carbon footprint, natural resources) and championing diversity, equity, and inclusion across our company and beyond.
GMP Senior Auditor Responsibilities:
1. Lead, support, and report independent GMP audits according to the Sandoz Quality System and current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
2. Review and approve corrective action plans supporting audit observations.
3. Perform audits of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers, including complex areas like sterile API, aseptic DP, and combination products.
4. Ensure alignment with strategic company directions and assist in implementing applicable actions.
5. Provide consultation through risk-based assessments and act as SME for assigned areas.
6. Support the development of a global risk-based audit strategy and plan.
7. Conduct, document, and follow-up on GMP audits per specified requirements.
8. Mentor junior GMP staff and provide technical guidance, training, and regulatory advice.
9. Prepare audit reports, escalate critical findings, and assess responses (CAPA plans) in collaboration with stakeholders.
10. Contribute to GMP training, continuous improvement projects, and policy reviews.
11. Maintain current knowledge of regulations, standards, and guidance documents.
12. Identify and share best practices and lessons learned to enhance GMP auditing and training.
Why Sandoz? We are a leader in generic and biosimilar medicines, touching the lives of nearly 500 million patients annually. Our investments in new capabilities, state-of-the-art sites, acquisitions, and partnerships allow us to shape the future of accessible, high-quality medicines sustainably.
Our culture is driven by openness, collaboration, and ambition, offering flexible, hybrid careers in a diverse and inclusive environment that encourages personal growth.
Commitment to Diversity & Inclusion:
Sandoz is dedicated to building an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.
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