Meda Pharma GmbH & Co KG
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.
Every day, we rise to the challenge to make a difference and here’s how the Global Operations Auditing (GOA) GMP Auditor (m/f/d) role will make an impact:

Key responsibilities for this role include:

• 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 Mylan 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.

Qualifications and Skills:

• 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 to 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 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.

LI-Remot

• 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 Mylan 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