Informacje o stanowisku

Job Description



Job responsibilities:

• Plan, lead, conduct, document, report, and follow-up of GMP audits according to the requirements specified in the respective Novartis/ Sandoz procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
• Audits will be focused on mid-low risk manufacturing and other GMP activities, on the basis of actual experience/expertise.
• Provide technical guidance and training on audit activities.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Novartis/ 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 the stakeholder QA representative and Auditee.
• Maintain current knowledge of regulations, standards, and guidance documents.

Job Requirements



Education (minimum/desirable):

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.
• Other degrees with relevant experience may be accepted.

Languages

• Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish).

Experience

• At least 10 years broad experience in Pharmaceutical or Medical Device Industry.
• The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
• 3 years auditing experience preferred, and excellent knowledge of regulatory requirements. Willingness to travel approx. 60% of the time.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• 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.

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!



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