GMDP Auditor, Quality Audit Excellence

Conducts cGMP, cGDP or device audits of suppliers and internal entities and systems in support of the supplier evaluation and risk assessment program.

Requirements

• Higher level education in natural science, pharmaceutical/medical subjects, or engineering (minimum bachelor’s degree) or equivalent professional experience.
• Minimum of 5 years of relevant industry experience including in Quality Assurance.
• Knowledge and understanding of the concepts of Quality Management Systems, the key regulations and guidelines, and the technology used in the manufacture, testing and distribution of medicinal products and medical devices.
• Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Astellas group and with external stakeholders.
• Proficiency in English.
• Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
• Ability to work independently, particularly to plan and execute audits in an effective and compliant manner with limited management oversight.

Benefits

• Basic salary
• Discretionary work allowance
• Housing allowance
• Commutation allowance
• Annual paid leave
• Childcare leave system
• Nursing care leave system
• Employment Insurance
• Industrial Accident Compensation Insurance
• Welfare Pension Insurance
• Health Insurance
• Mutual Aid Association System
• Company Housing System
• Employee Shareholder Association System
• Property Accumulation Savings System
• Bonus
• Allowance for overtime work