Global Quality Auditor

3 settimane fa

Milano, Italia Viatris A tempo pieno

7092 Mylan Italia S.r.l.

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 Quality Auditor role will make an impact:
Key responsibilities for this role include:

- Prepare and conduct internal and external audits for Viatris
- Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited
- Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management
- Provide interpretation of complex regulations through research of current corporate 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 actions
- Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards
- Author and approve Quality Compliance 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 frequent domestic and international travel
- Perform other duties as assigned.

The minimum qualifications for this role are:

- Minimum of a Bachelor's degree (or equivalent) and minimum of 6 years of experience. However, a combination of experience and/or education will be taken into consideration
- Position functions within a team structure with no direct supervisory requirements. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include planning, assigning, and directing work
- Ability to read and interpret comlex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments. Must be proficient in spoken and written English
- Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately 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.

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