Global GMP Quality Auditor

323468BR
Sep 09, 2021
Spain

Job Description

[Global GMP Senior Quality Auditor]

As Global GMP Quality Auditor you will 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 include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
To learn more about Novartis Spain, visit: http://www.novartis.es/

Your responsibilities include, but not limited to:

1. Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
2. 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, quality agreements, and guidance documents.
3. For this role, auditors will be given more complex and higher-risk audits, such as sterile API/DP, medical devices, biotechnological and combination products, gene therapies, radiotherapeutics, Due Diligences and Mock-PAI audits. The ability to assess risk of these operations is critical to success.
4. Provide technical guidance, mentoring, and training on audit activities.
5. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
6. Prepare audit reports according to NVS requirements and timelines.
7. 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.
8. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee


Minimum Requirements

What you’ll bring to the role:
• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science
• 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.
• At least 12 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 5 years auditing experience, including preferably auditor certification by an industry recognized body (e.g. ASQ) and excellent knowledge of regulatory requirements.
• Willingness to travel approximately 50% of the time.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, Biotechnological and Combination products, Gene therapies, radiotherapeutics, APIs, Excipients, Sterile manufacturing, 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.

You’ll receive:
Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours;


Why Novartis
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.


We are Novartis. Join us and help us reimagine medicine.



Once your application has been received via our Novartis careers portal, your CV will be reviewed by our team of recruiters. If shortlisted, if shortlisted you can expect a call from an international number.
Novartis Technical Operations
NTO QUALITY
Spain
Barcelona
Quality
Full Time
Regular
No
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323468BR

Global GMP Quality Auditor

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