社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
...
Quality Assurance Line ManagerOn the basis of company quality policy and Japanese Pharmaceutical law, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese CMOs in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and marketing authorization holder.Responsibilities:Manage and supervise External Manufacturers under GMP defined in MHLW Ministerial Ordinance No.179Regulatory and Quality (J-pharmaceuticals law and company quality directives) Compliance(Rank should be handled as no. 1 as well)Management of EMQA organizationManagement of CMC compliance through sustainable monitoring and appropriate approach to the authoritySupport other divisions (Business Units, Pharmacovigilance, Medical Affairs, External Affairs, Regulatory Affairs, R&D and Supply Chain) with expertized QA approachQuality service for products manufactured in CMOs to the sales companiesCreate supportive & comfortable work environment. No accident. Reporting to global quality, monthly report, KPI with appropriate tool and defined frequency
求められる経験
Qualifications:
Pharmaceutical Affairs Law, GMP, GQP
Quality Assurance, fundamental knowledge of manufacturing / packaging
Scientific knowledge (e.g. chemistry, biology, biochemistry, pharmacy)
Foreign language ability (English),
Business skills (communication, resource/risk management, decision making, logical thinking, negotiation, leadership, debate)
[Formal Education and/or Experience Required]
University or higher level of educational background in the field of Science.
GMP, GQP, Pharmaceuticals law and the related regulations
QA experience more than 3 years with additional experience in manufacturing or quality control
保険
健康保険,雇用保険
休日休暇
祝日
給与
年収1,300 ~ 1,700万円
賞与
-
show lessshow more
社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
Quality Assurance Line ManagerOn the basis of company quality policy and Japanese Pharmaceutical law, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese CMOs in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and marketing authorization holder.Responsibilities:Manage and supervise External Manufacturers under GMP defined in MHLW Ministerial Ordinance No.179Regulatory and Quality (J-pharmaceuticals law and company quality directives) Compliance(Rank should be handled as no. 1 as well)Management of EMQA organizationManagement of CMC compliance through sustainable monitoring and appropriate approach to the authoritySupport other divisions (Business Units, Pharmacovigilance, Medical Affairs, External Affairs, Regulatory Affairs, R&D and Supply Chain) with expertized QA approachQuality service for products manufactured in CMOs to the sales companiesCreate supportive & comfortable work environment. No accident. Reporting to global quality, monthly report, KPI with appropriate tool and defined frequency
...
求められる経験
Qualifications:
Pharmaceutical Affairs Law, GMP, GQP
Quality Assurance, fundamental knowledge of manufacturing / packaging
Scientific knowledge (e.g. chemistry, biology, biochemistry, pharmacy)
Foreign language ability (English),
Business skills (communication, resource/risk management, decision making, logical thinking, negotiation, leadership, debate)
[Formal Education and/or Experience Required]
University or higher level of educational background in the field of Science.
GMP, GQP, Pharmaceuticals law and the related regulations
QA experience more than 3 years with additional experience in manufacturing or quality control
保険
健康保険,雇用保険
休日休暇
祝日
給与
年収1,300 ~ 1,700万円
賞与
-
show lessshow more