MSD Specialist Quality Systems & Compliance 

Japan, Chiyoda 

683122303

Job Description

【Main Responsibilities】

Quality Assurance activities of the Marketing Authorization Holder as described below:

• Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.
• Establishes and maintains robust local procedures to support implementation of all Quality Assurance activities as defined in the GQP regulations.
• Supports the preparation, implementation, and follow-up activities relating to GQP regulatory inspections for Marketing Authorization license renewal.
• Critically assess Quality Systems and their implementation to ensure procedures are followed appropriately. Supports the generation of and tracking of CAPAs, as part of the GQP self-inspection process.
• Drives proactive and continuous improvement of all GQP processes.
• Performs market release of products including management of the release schedule and ensures a robust release process.
• Ensures Quality Agreements are in place with all manufacturers and fully meets the intent and requirements of GQP.
• Coordinates and implements the GQP training program.
• Supports Computer System Validation activities relating to GQP systems.
• Ensures Quality Standard Codes for allour companyproducts are maintained as current.
• Supports coordination of any recall activities across a cross-functional team.
• Collaborates cross-functionally with the Office of the Marketing Supervisor General, Pharmacovigilance Department, Regulatory Affairs Department, local manufacturing sites, and global sites to perform GQP activities.

【Qualifications】

BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) required.

Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities. Must have strong demonstrated communication skills in Japanese and English. Must be conversant with applicable regulations governing operations. Some level of contractual and financial awareness is preferred. Highly motivated individual, with strong interpersonal and leadership skills.

Current Contingent Workers apply

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