CHIE HIGASHIKUBO
Manager at Shionogi & Co., Ltd- Claim this Profile
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Bio
Experience
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Shionogi & Co., Ltd
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Manager
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Apr 1992 - Present
QUALIFICATIONS Ensure compliance of the operations with the standards of Shionogi policies and procedures and any applicable regulations - Global PV (pharmacovigilance) audit (In-house PV activities, CRO/Vendor, Affiliate, License Partner in Asian region) (since 2012) - Local GVP* audit (*Good Vigilance Practice, GPSP* audit, *Good Post-marketing Study Practice) (Since 2012) - GCP audit (On-site, CRO/Vendor) (since 2012) - GxP Computerized System Vendor Audit (Global region) - Excellent communication skill with auditee - 12 years’ audit experience in GLP (From 1999 to 2011) - More than 10 years' audit experience in GCP/PV - Certificate in pharmacist Show less
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