|職名||Global Senior GMP Quality Auditor|
|勤務地||Japan - Tokyo|
Global Pharmaceutical Company
1. Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
2. For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.
3. Provide technical guidance, mentoring, and training on audit activities.
4. Proactively research local and global initiatives, trends, and events that affect maintenance of compliance.
5. Mentor junior GMP staff as required.
6. Maintain current knowledge of regulations, standards, and guidance
• Degree in Chemistry, Pharmacy, Biology, Engineering or another related
• Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred.
• At least 12 years broad experience in Pharmaceutical or Medical Device
• The operational experience should include QA/QC management and
manufacturing, or development or other relevant experience e.g. working at a
regulatory health authority.
• At least 5 years auditing experience, including preferably auditor certification
by an industry recognized body (e.g. ASQ) and excellent knowledge of
• Willingness to travel approximately 60% of the time.
• Expertise in at least one of the following areas: DP Manufacturing,
Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics,
Microbiology, Computer System Validation, Packaging activities, Quality
• Experience and/or interaction with local Health Authority and sporadically with
other Health Authorities.