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新着求人 品質保証  (FA-79)
募集職種 外資系製薬企業の GMPバリデーション担当
勤務地 滋賀
会社概要 非公開
求人要件 【職務内容】
・Research on recent and future requirements of validation of QC testing, inspection, packing and quality assurance processes including equipment and computerized systems in laws, regulations, ** Standards and industry standards.
・Assess compliance of Japan Operation’s processes to the above and identify improvement areas.
・Perform the Validation improvement plan and actions.( Improve the Cleaning Validation activities.
Continued process Verification activities. Etc.)
・Develop the ** Validation Master Plan and Report and review for individual Validation activities to avoid any critical issues related to Validation activities with Validation Manager.
・Review the Validation documents and Develop the Site Validation Master Plan /Report.
・Correspond external and internal audit adequately to avoid critical observations related to Validation
・Plan for further improvements.
・Develop ,revise and maintain the Validation SOPs to ensure the Validation governance
・Support/Facilitate the Equipment Management and Validation Committee.
・Develop and train the Validation staffs and suppliers
・Enhance and promote work/life balance for staff and through effective work planning and resourcing in accordance with ** code of conduct, SHE and all applicable ** policies
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