コンピュータシステム品質保証/ Computer Systems QA

An international pharmaceutical company is seeking a Computer Systems QA. The selected candidate will oversee computer system development, validation, and maintenance while ensuring compliance and inspection readiness.

Responsibilities:

• Provide quality oversight of computerised systems
• Review and approve documents supporting system validation, including procedures, deviations, periodic reviews, and change proposals
• Offer guidance and recommendations for computer system issues
• Conduct gap assessments against global requirements and implement governing standards
• Review and approve automation-related work orders
• Coach, mentor, and provide feedback to QA and site personnel on computerised systems and validation
• Ensure compliance with data integrity requirements during validation and routine operations
• Participate in site data integrity strategy and assessments
• Lead or support investigations into computer system incidents and deviations
• Review and revise global quality standards related to computerised systems as needed
• Maintain inspection readiness in supported areas
• Participate in regulatory inspections and audits
• Interpret regulatory and corporate requirements for computerised systems
• Establish and maintain site quality systems for compliance with Japanese GMP, computer system guidelines, and quality standards

Requirements:

• Bachelor’s degree or equivalent in chemistry, engineering, computer science, mathematics, or a science-related field
• Prior GMP work experience in the pharmaceutical industry
• Experience with manufacturing processes or computer systems, including validation
• Understanding of local and global regulations (e.g., CFR Part 11)
• Proficient in GMP computer system validation and governing regulations
• Native level Japanese; proficient in English (TOEIC 750+)

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:

製薬業界, コンピュータ化システム, 品質保証, バリデーション, データ完全性, 規制コンプライアンス, システム監査, 求人, 外資系

Job Ref: IHVCKE