GMP Auditor – Global Operations

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September 30

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Viatris

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Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Participate and/or lead internal site or external supplier/contractor audits • Perform independent research of FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational (GxP and ICH) regulations and guidance documents • Provide independent review, comprehension, and discussion of departmental, regional and global policies and procedures • Provide interpretation of complex regulations and guidance documents • Perform GxP internal and external audits based on a defined audit plan • Facilitate opening and closing audit meetings and prepare associated documentation including audit plans and audit reports under strict confidentiality • Track and monitor audit responses and the implementation of corrective and preventative actions • Provide guidance and support in the development of corrective and preventative actions • Author and approve procedures • Serve as a compliance reference regarding GxP Interpretations • Serve as a liaison within the many GxP departments of Viatris • Plan, schedule, and arrange travel to various sites; requires domestic and international travel (~50%)

🎯 Requirements

• Minimum of a Bachelor’s degree • Minimum of 6 years relevant GMP experience • A combination of experience and/or education will be taken into consideration • Ability to read and interpret complex business and/or technical documents • Ability to write comprehensive reports and detailed business correspondence • Ability to work with managers or directors to communicate ambiguous concepts • Ability to present groups across the organization • Ability to understand technical documents and communicate description of potential problems and/or solutions • Ability to solve equations, apply mathematical concepts, and perform computations • Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis • Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems

🏖️ Benefits

• competitive salaries, benefits and an inclusive environment • opportunity to access excellent career progression opportunities • work-life balance initiatives