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
...
Primary purpose/function of the job:Manage third party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMPs activities.Serve as functional quality representative of external manufacturing Japan for CMOs in work scope. Ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activitiesAny ad hoc tasks assigned by the reporting ManagerCandidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have good communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.Quality Management of third-party manufacturers：・Perform GMP audits of third-party manufacturers and CAPA (Corrective action and preventive action) follow-up.・Complaints management. Review complaints investigation, CAPA plan and effectiveness review. ・Monitoring of complaints trend.・Management and support for product recall and return.・Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.・Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.・Participate in the evaluation, selection, and approval of third-party manufacturers.・Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.・Management of Product Quality Reviews (PQR). ・Review of PQR, corrections/follow up action.・Monitoring of PQRs trend.・Review of technical reports e.g., stability reports, process /analytical validation reports etc. ・Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.・Management of Quality and Safety Material ・Product (QSMP). Setup / coordinate / review / update of QSMP.・Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.・Perform risk ranking of third-party manufacturers.・Manage termination of activity with third party manufacturers. Quality Operations of EM CHC Japan Entity：・Support/perform management and continuous improvement of Quality Management System (QMS) in alignment with EM CHC AMEA & China.・Support/perform implementation of global quality systems, standards and procedures.・Support Quality Documentation System management, documentation Retention, Archival and Destruction.・Support/perform Qualifications and Training of ・Quality/Regulatory personnel.・Support/perform Self Inspection.・Prepare and participate in EM CHC Japan / EM AMEA & China Quality Review.・Support/prepare Monthly Quality Reports for reporting to Global Quality.・Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers for reporting to Global Quality.Quality Support for Transversal Projects：・Provide Quality support for transversal project e.g., new product launch, site transfer or repatriation.
求められる経験
[Knowledge & Skill]
* 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 bac ground 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,厚生年金保険,雇用保険,労災保険
待遇・福利厚生
休憩室
各種福利厚生制度あり
受動喫煙防止に関する取り組みあり
休日休暇
日曜日,土曜日,祝日
完全週休二日制、ほか
給与
年収800 ～ 1,100万円
賞与
-
show 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
...
Primary purpose/function of the job:Manage third party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMPs activities.Serve as functional quality representative of external manufacturing Japan for CMOs in work scope. Ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activitiesAny ad hoc tasks assigned by the reporting ManagerCandidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have good communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.Quality Management of third-party manufacturers：・Perform GMP audits of third-party manufacturers and CAPA (Corrective action and preventive action) follow-up.・Complaints management. Review complaints investigation, CAPA plan and effectiveness review. ・Monitoring of complaints trend.・Management and support for product recall and return.・Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.・Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.・Participate in the evaluation, selection, and approval of third-party manufacturers.・Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.・Management of Product Quality Reviews (PQR). ・Review of PQR, corrections/follow up action.・Monitoring of PQRs trend.・Review of technical reports e.g., stability reports, process /analytical validation reports etc. ・Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.・Management of Quality and Safety Material ・Product (QSMP). Setup / coordinate / review / update of QSMP.・Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.・Perform risk ranking of third-party manufacturers.・Manage termination of activity with third party manufacturers. Quality Operations of EM CHC Japan Entity：・Support/perform management and continuous improvement of Quality Management System (QMS) in alignment with EM CHC AMEA & China.・Support/perform implementation of global quality systems, standards and procedures.・Support Quality Documentation System management, documentation Retention, Archival and Destruction.・Support/perform Qualifications and Training of ・Quality/Regulatory personnel.・Support/perform Self Inspection.・Prepare and participate in EM CHC Japan / EM AMEA & China Quality Review.・Support/prepare Monthly Quality Reports for reporting to Global Quality.・Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers for reporting to Global Quality.Quality Support for Transversal Projects：・Provide Quality support for transversal project e.g., new product launch, site transfer or repatriation.
求められる経験
[Knowledge & Skill]
* 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 bac ground 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,厚生年金保険,雇用保険,労災保険
待遇・福利厚生
休憩室
各種福利厚生制度あり
受動喫煙防止に関する取り組みあり
休日休暇
日曜日,土曜日,祝日
完全週休二日制、ほか
給与
年収800 ～ 1,100万円
賞与
-
show more
