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

Viatris; Lyon; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A global healthcare firm in Lyon is seeking a Global Operations Auditor to ensure compliance with GMP regulations through internal and external audits. The successful candidate will have a Bachelor's degree and at least 6 years of GMP experience. The role requires travel approximately 50% of the time and strong skills in auditing and regulatory compliance.

Prestations

Competitive salaries

Career progression opportunities

Work-life balance initiatives

Qualifications

• Minimum of 6 years relevant GMP experience.
• Ability to read and interpret complex documents.
• Ability to write comprehensive reports.
• Ability to communicate ambiguous concepts.

Responsabilités

• Participate and lead internal and external audits.
• Perform independent research on regulations.
• Provide guidance on corrective actions.

Connaissances

Auditing

Time Management

ICD-10

Accounting

Component evaluation

Workers' Compensation Law

SOX

Microsoft Excel

CPT Coding

Internal Audits

Medicare

Bookkeeping

Formation

Bachelor's degree

Outils

Microsoft Excel

Description du poste

Viatris Sant

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

Every day we rise to the challenge to make a difference and here’s how the Global Operations Audit - GMP Auditor role will make an impact:

• 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

For this role we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelors 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 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 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.

Viatris is an Equal Opportunity Employer.

Key Skills

• Auditing
• Time Management
• ICD-10
• Accounting
• Component evaluation
• Workers' Compensation Law
• SOX
• Microsoft Excel
• CPT Coding
• Internal Audits
• Medicare
• Bookkeeping

Employment Type: Full-Time

Experience: years

Vacancy: 1