GMP Auditor – Global Operations
Viatris
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇫🇷 France
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPGxPauditingregulatory compliancedocument interpretationreport writingcorrective actionspreventative actionsmathematical conceptsproblem solving
Soft skills
communicationpresentationindependent judgmentanalytical thinkingdeductive reasoningcollaborationconfidentialityorganizational skillsresearch skillsliaison