Global GMP Senior Auditor

hace 3 días

Centro, España Healthcare Businesswomen’s Association A tiempo completo

Job Description Summary

The future is (y)ours to shape

Job Description

At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:

  • Finding the right balance between guaranteed quality, reliable supply, and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.
  • To protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity, and inclusion across our company and beyond.

As a GMP Senior Auditor, you'll lead, support, and report independent GMP audits according to the Sandoz 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.

Ensure alignment with the strategic direction of the company and assist in driving the implementation of the applicable actions. Provide consultation to Sandoz business units through risk-based assessments. Act as SME for assigned areas of responsibility.

Your responsibilities will include:

  • 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.
  • Plan, lead, conduct, document, and follow-up of GMP audits according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
  • For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess the risk of these operations is critical to success.
  • Provide technical guidance, mentoring, and training on audit activities.
  • Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
  • Prepare audit reports according to Sandoz requirements and timelines.
  • Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to 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.
  • Act as GMP compliance consultant for GMP trainings, task forces, and continuous improvement projects as needed. Assure permanent transfer of best practices identified during the audit into the Sandoz QMS system.
  • Review and advise on relevant policies and procedures.
  • Mentor junior GMP staff as required.
  • Maintain current knowledge of regulations, standards, and guidance documents.
  • Identify and report best practices and lessons learned to support development/training of GMP auditors.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is (y)ours to shape

Commitment to Diversity & Inclusion:

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

Pioneering access for patients

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

#Sandoz

Skills Desired

Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, GMP Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Quality Assurance, Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise.

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