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Global GMP Senior Auditor

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Sandoz

28d ago

  • Job
    Full-time
    Senior Level
  • Madrid

AI generated summary

  • You need a Bachelor's in Life Sciences, 5+ years in GMP audits, strong regulatory knowledge, auditing experience, and excellent communication skills. Travel is necessary; mentoring skills are a plus.
  • You will plan and conduct complex GMP audits, provide guidance and training, document findings, assess CAPA plans, and ensure compliance with regulations while mentoring junior staff.

Requirements

  • - Bachelor's degree in Life Sciences or related field
  • - Minimum 5 years of experience in a GMP audit role
  • - Strong knowledge of current GMP regulations, standards, and guidance documents
  • - Experience in auditing manufacturing sites, development centers, quality systems, and laboratories
  • - Excellent communication and interpersonal skills
  • - Ability to mentor and train junior staff
  • - Strong analytical and risk assessment skills
  • - Proficiency in preparing detailed audit reports
  • - Ability to work effectively in a collaborative and diverse environment
  • - Willingness to travel as required for audits

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.

FAQs

What is the primary responsibility of the Global GMP Senior Auditor?

The primary responsibility is to lead, support, and report independent GMP audits to assess compliance with applicable regulations, standards, and guidance documents.

What types of audits will the GMP Senior Auditor perform?

The GMP Senior Auditor will conduct internal and external audits targeting manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, and suppliers.

Will the GMP Senior Auditor need to assess risk during audits?

Yes, the ability to assess risk, especially for complex and higher-risk audits, such as sterile API, aseptic DP, and combination products, is critical to success.

What kind of training and mentoring opportunities are available in this role?

The GMP Senior Auditor will provide technical guidance, mentoring, and training on audit activities and may also mentor junior GMP staff as required.

How does the GMP Senior Auditor ensure compliance with audit findings?

The auditor assesses the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee, and provides regulatory guidance for timely remediation.

Is there a focus on diversity and inclusion in Sandoz’s work environment?

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

What role does the GMP Senior Auditor play in continuous improvement initiatives?

The auditor will act as a GMP compliance consultant for task forces and continuous improvement projects, ensuring the transfer of best practices identified during audits into the Sandoz QMS system.

How can I stay connected with Sandoz if I'm not applying for this role?

You can join the Sandoz Talentpool to stay connected and hear more about career opportunities at Sandoz.

What is the strategic goal of Sandoz as a company?

Sandoz aims to increase access to high-quality medicines in a sustainable and responsible way while maintaining a balance between quality, reliable supply, and appropriate pricing.

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Sandoz

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

Sandoz, a global leader in generic pharmaceuticals and biosimilars, is dedicated to improving access to high-quality, affordable medicines for patients worldwide. Their ultimate mission is to expand access to essential healthcare by developing and providing generic and biosimilar medicines that meet rigorous quality standards. Sandoz aims to make healthcare more accessible and affordable, ensuring that patients benefit from high-quality treatments and contributing to the overall improvement of global health outcomes. Their purpose is to enhance the quality of life for people by delivering cost-effective, innovative solutions in the pharmaceutical industry.