Global GMP Senior Auditor

Sandoz Iberia; España; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A global leader in generic medicines is seeking a GMP Senior Auditor. The role involves leading GMP audits, assessing compliance with regulations, and ensuring quality standards are met. Candidates should possess over 10 years of experience in the pharmaceutical industry and strong auditing skills. Travel is required approximately 60% of the time, and excellent communication abilities in English are essential.

Formación

• At least 10 years of experience in Pharmaceutical or Medical Device Industry.
• 3 years auditing experience preferred, excellent knowledge of regulatory requirements.
• Willingness to travel approximately 60% of the time.

Responsabilidades

• Lead and conduct GMP audits according to regulations and Sandoz Quality System.
• Plan the global risk-based audit strategy.
• Prepare audit reports and ensure management escalation for critical findings.

Conocimientos

Excellent oral and written English skills

Interpersonal skills

Ability to manage complex compliance issues

Educación

Degree in Chemistry, Pharmacy, Biology, Engineering or related science

Advanced degree preferred

Descripción del empleo

Overview

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

Position

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

Responsibilities

• 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 audit 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 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, continuous improvement projects as needed. Assure permanent transfer of best practice 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 development / training of GMP auditors.

What You Need To Bring To The Role

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted
• Excellent oral and written English communication skills. Good knowledge / mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is valued.
• At least 10 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.
• 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
• Willingness to travel approximately 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.
• 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.
• Sound and practical judgement in the interpretation and application of regulations and standards
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision
• Excellent leadership and facilitation skills

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.

Pioneering access for patients

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