Global Operations Audit - GMP Auditor H/F/D - CDI

Viatris; Lacaussade; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A global healthcare company is seeking a Global Operations Auditor in Lacaussade, France. The role involves conducting compliance audits, ensuring GMP guidelines are met, and collaborating with various departments. Ideal candidates will have at least a Bachelor’s degree and 6 years of relevant experience. Join this innovative firm focused on improving health worldwide in an inclusive work environment.

Prestations

Competitive salary

Career progression opportunities

Work-life balance initiatives

Qualifications

• Minimum of 6 years of relevant GMP experience.
• Ability to understand and communicate complex regulations.
• Experience conducting audits and developing corrective actions.

Responsabilités

• Lead internal and external audits based on expertise.
• Research and interpret regulatory guidelines.
• Track and monitor audit responses and corrective actions.
• Serve as a compliance reference for all levels of Management.

Connaissances

Ability to read and interpret complex documents

Ability to write comprehensive reports

Analytical problem solving

Independent judgment and analysis

Ability to present concepts to diverse groups

Formation

Bachelor's degree

Description du poste

Overview

Viatris Santé

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Global Operations Auditor is a critical role for qualification of Third Party Suppliers, according to key regulatory GMP guidelines as applicable, assuring the GMP compliance of the audited facilities. This position will work with a high level of independence and actively coordinate/participate in activities with global and local functions across Viatris as applicable.

The Role & What You Will Be Doing

• Participate and/or lead internal site or external supplier/contractor audits, as required, based upon areas of expertise.
• 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 including assessment of applicability and impact on systems being audited.
• Provide independent review, comprehension, and discussion of departmental, regional and global policies and procedures with multiple levels of employees and Management.
• Provide interpretation of complex regulations and guidance documents through research of current regional, global and governmental expectations.
• Perform GxP internal and external audits based on a defined audit plan within specific time constraints, including the facilitation of opening and closing audit meetings with all levels of Management, the preparation of all associated documentation including audit plans and audit reports under strict confidentiality, and 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 based on GxP regulations, guidance documents and current industry standards.
• Author and approve procedures.
• Serve as a compliance reference regarding GxP Interpretations for all levels of Management.
• Serve as a liaison within the many GxP departments of Viatris to effectively establish compliant quality systems.
• Plan, schedule, and arrange travel to various sites based upon guidance from Management.
• Requires domestic and international travel (approximately 50% of the time).
• Perform other duties as assigned.

About Your Skills & Experience

• Minimum of a Bachelor’s degree and 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.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.