Senior Quality Assurance Auditor
4 weeks ago
As a Senior Quality Assurance Auditor, you will lead, support, and report independent GMP audits to assess compliance with applicable regulations, standards, and guidance documents. You will review and approve corrective action plans in support of the audit observations. The audits will include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
You will ensure alignment with the strategic direction of the company and assist in driving implementation of the applicable actions. You will provide consultation to Novartis business units through risk-based assessments.
Key Responsibilities:- Support the strategic development of an effective global risk-based audit strategy and program.
- Plan, lead, conduct, document, and follow up on GMP audits according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
- Provide technical guidance, mentoring, and training on audit activities.
- Provide regulatory guidance for timely remediation and recommendations regarding the acceptability of the proposed filing.
- Prepare audit reports according to NVS requirements and timelines.
- Identify and report best practices and lessons learned to support development/training of GMP auditors.
- 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.
- At least 12 years broad experience in the Pharmaceutical or Medical Device Industry.
- 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.
Functional Area: Quality
Job Type: Full time
Employment Type: Regular
Shift Work: No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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