プリンシパルサイエンティストクオリティオーディター/ Principal Scientist Quality Auditor

A global pharmaceutical company is looking for a Principal Scientist Quality Auditor. The selected candidate will be responsible for conducting internal and external audits, ensuring compliance with regulations, and contributing to QA efforts.

Responsibilities:

• Schedule, prepare, conduct, and report GQAAC audits of GXP operations to assess compliance with company standards and regulations
• Lead or participate in the risk assessment of GXP operations to contribute to the annual audit plan
• Escalate any compliance issues appropriately and maintain knowledge of applicable regulations and technical standards
• Assist in the preparation or review of quality-related policies, procedures, and standards
• Provide advice on GXP requirements and support regulatory inspections as needed
• Develop and deliver quality and compliance education, and support the training of other auditors

Requirements:

• Bachelor’s degree or above in physical/biological sciences, engineering, or a related field
• More than 5 years of relevant experience in GCP medical auditing within the pharmaceutical environment
• Experience working with third-party organisations
• Skilled in interpreting and applying regulations and providing compliance recommendations
• Proficient in data entry and analysis
• Ability and willingness to travel domestically and internationally
• Possess a valid authorisation to work in Japan
• Native level Japanese; proficient verbal and written English

About the Company:

A reliable supplier of pharmaceutical solutions and high-quality medicines for decades. With a clear vision and a commitment to improvement, the company is recognised as a leader in its field.

Keywords:

品質監査, 医薬品, グローバルチーム, リスク評価, 規制遵守, 訓練, 求人, 外資系

2131050/001