Global GMP Auditor

Global GMP Auditor

Sandoz

Warsaw, Poland

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 to 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) is preferred

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 latest, 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

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