Audit & Compliance Professional

Job Description Summary

The Audit & Compliance Professional manages cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
Performs preparation and management of external and corporate audits and Health Authority inspections.

 

Job Description

Major Accountabilities:

• Plan, lead, conduct, document, report, and follow-up of GMP audits according to the requirements specified in the respective Novartis 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 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 stakeholder QA representative and Auditee.

• Maintain current knowledge of regulations, standards, and guidance documents.

Essential requirements:

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.

• At least 10 years broad experience in Pharmaceutical or Medical Device Industry including QA/QC management and manufacturing, 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.

• Strong interpersonal skills and fluency in English, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Skills Desired

Collaboration, Data Integrity, Decision Making, Leadership, Risk Management