Your Key Responsibilities Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan. Plan, lead, conduct, document, and follow-up of PV audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents. Provide technical guidance, mentoring, and training on audit activities. Prepare audit reports according to Sandoz requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow up Responsible Person (FURP) and Quality Responsible Person (QARP). Support Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed. Review and advise on relevant policies and procedures. Maintain current knowledge of regulations, standards, and guidance documents. Identify and report best practices and lessons learned to support development/training of PV auditors. What you'll bring to the role: Degree in Sciences At least 3-5 years of PV Auditing experience Willingness to travel approximately 60% of the time The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority Extensive knowledge of applicable PV regulations, guidelines, policies and procedures Experience with Health Authority inspections and interaction. Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Sandoz colleagues, vendors and customers. Sound and practical judgement in the interpretation and application of regulations and standards Fluent in English written and spoken, other languages are a plus You'll receive: Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged!
The future is ours to shape!
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.
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