Global Quality Auditor

315892BR
Mar 30, 2021
China

Job Description

18 million Chinese patients benefit from Novartis products!

Major Accountabilities
●Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed on behalf of Audit and Incident Management include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, and suppliers.
●Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, and guidance documents.
●Provide technical guidance and training on audit activities.
●Audits include pre-qualification audits, routine GMP surveillance audits (both System Based audits and audit focused on special areas/functions e.g. on Stability Program), for cause audits, and mock inspections at suppliers/contractors.
●Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
●Prepare audit reports according to NVS requirements and timelines.
●Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS 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 Follow-up Responsible Person (FURP) and Auditee (Quality Responsible Person, QARP).

Minimum Requirements

●Degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
●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.
●At least 3 years auditing experience, including preferably auditor certification by an industry recognized body e.g. ASQ and excellent knowledge of regulatory requirements.
●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 Novartis colleagues, vendors and customers.
●Sound and practical judgment in the interpretation and application of regulations and standards
Novartis Technical Operations
NTO QUALITY
China
Shanghai
Quality
Full Time
Regular
No
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315892BR

Global Quality Auditor

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