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新着求人 品質保証  (FA-14)
募集職種 外資系製薬企業の Quality Assurance Specialist
勤務地 埼玉
会社概要 非公開
求人要件 【職務内容】
Position Overview
Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with MMD requirements and regulatory requirements and expectations.
Under his/her responsibilities fall the quality oversight for
•Supplier Quality Management.
•Receipt, handling, storage, and disposition of products and components
•Batch record review and Release
•Deviation investigations
•Corrective and preventive actions (CAPA) investigation, management and approval
The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Assurance Manager) with regards to the above described activities.
The role has newly formed with organizational changes, thus shifting of responsibilities in near future is acceptable.
Skills (include specific skill levels required to apply Merck Leadership Principles)
•Degree in Life Sciences, Engineering or related relevant discipline.
•Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
•Knowledgeable of Japanese and global authority quality and compliance requirements
•Knowledgeable in Industry Best Practices for quality and compliance related topics.
•Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
•Preferably have project management skills.
•Preferably have previous experience in Supplier Management, Risk Assessment, Deviation Management in pharma or med device environment
•Be ready to act as change agent
•Good Japanese and English communication skills
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