Global GMP Senior Auditor

Sandoz International GmbH; Madrid; Presencial; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

An established industry player in the pharmaceutical sector is seeking a GMP Senior Auditor to lead independent audits and ensure compliance with quality standards. This role involves assessing manufacturing sites, providing regulatory guidance, and mentoring junior auditors. The company values sustainability and diversity, aiming to shape the future of medicine access. Join a collaborative environment where your expertise will make a significant impact on global health by ensuring the highest quality in pharmaceutical practices. Be part of a team dedicated to improving patient outcomes through innovative solutions and best practices.

Servicios

Flexible hybrid work environment

Professional development opportunities

Health and wellness programs

Diversity and inclusion initiatives

Formación

• Lead and conduct GMP audits in compliance with regulations.
• Provide technical guidance and mentoring to junior staff.

Responsabilidades

• Plan, conduct, and document GMP audits for compliance.
• Assess risks and provide regulatory guidance for remediation.

Conocimientos

GMP Auditing

Risk Assessment

Technical Guidance

Regulatory Compliance

Mentoring

Educación

Bachelor's degree in Life Sciences

Relevant certifications in GMP

Herramientas

Sandoz Quality System

Audit Management Software

Descripción del empleo

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 on 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 the 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 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 the 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 is 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.