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
...
PurposeTo implement and monitor Quality Management System for products manufactured by CMOs for EM Japan, to ensure the compliance as per cGMP and applicable Global quality standards.Performance Standards: Duties & Responsibilities1.Change Control Management: 18%Manage Change controls received from CMO and EM Japan cross-functions through global database (example Phenix ) as per requirements of global quality standards and procedures and local SOP with the assistance from Team support executives. Coordinate with Quality manager/ CMO managers (if required) for Quality evaluation of CC , assign CC to regulatory team for the regulatory evaluation Approve/reject the CC request with assignment of work plan where applicable Follow up on implementation of work plan by respective work-leaders and approve and close the CC in global database Maintain and report monthly KPI for the CC.2.Events and CAPA Management: 10%Manage Events/deviations/incidents/OOS/OOT received from CMO and EM Japan cross-functions through global database (example Phenix ) as per global quality standards and procedures and local SOP, with the assistance from Team support executives. Coordinate with Area responsible manager for acceptance or rejections of deviation, follow up for the completed deviation/OOS/OOT report. Define & assign appropriate CAPA /tasks where required to respective Quality manager for execution. Approve and close the deviation/OOS/OOT in global database( example Phenix) & Maintain and report monthly KPI , for the Events and CAPA3.Quality Risk Management: 5%Manage and raise risk for the appropriate events in global database as per requirements of global quality standards and procedures by aligning discussion with the Head QO and Head EM. Ensure completion of investigation reports by respective Quality manager Circulate RQN as per Global distribution list , Arrange Quality Alert meeting with Global stakeholders, prepare circulate MOM. Update the appropriate action plan on timely manner in global database . Conduct quarterly risk review meeting with global quality alert manager Maintain and report monthly KPI for risks reported in global database4. Market complaints: 5%Ensure market complaints are managed as per requirements of global quality standards and procedures Ensure communication of Market complaint to respective Quality manager , completion of investigations and closure in timely manner unless justified with documentation . Ensure CAPA are in place wherever required. Trend analysis of market complaint as per SOP. Maintain and report monthly KPI for the market complaint.5. In place In use Management: 10%Implement “In Place In Use” Programme for Global Quality Standards and procedures applicable for EM Japan Define the implementation plan – for the updated applicable standards , do the gap assessment as per the defined IPIU programme Maintain and report monthly KPI for IN place in Use program.6.QSTP alerts: 2.5%Assess the impact of QSTP alerts received from the Global on EM Japan portfolio. Coordinate with Quality manager and by discussion with head QO, for risk assessment ,assign respective CAPA to Quality managers for the implementation. Response to Global QSTP team for the action plan and its status in case of alerts.7. Document Management (Geode+) : 10%Coordinate with TSEs and Quality manager and ensure maintenance of GMP documents in Geode + for EM Japan with proper documental approval flow Maintain and revise EM SOP as per the schedule. Coordinate with TSEs and Quality manager , maintain and revise Specification RM/FP as per the schedule. Approve the documents in Geode+.8.Training : 10%Prepare and maintain training schedule for EM Japan Quality team. Identify the Training needs for the EM Team and plan training for the same. Schedule training as per the Training calendar. Maintain and report monthly KPI for training.9.QTP Database : 2.5%Coordinate with team support executive and ensure maintenance and periodic updation of QTP( QualityThird Party ) data in global database system ( example phenix )10.Audit Readiness: 10%Participate and execute the Audit readiness tool as per requirements of Global Quality by discussion with Quality managers.11.Project Management: 10%Support and execute for the project assigned as per EM Japan project management team. (Risk assessment , Quality agreement QSMP with reporting of monthly KPI )12.cGMP Audit: 7%Plan and execute the GMP audit assigned as per Audit calendar.
求められる経験
Pre-requisites:
Knowledge, Skills & Competencies / Language
Sound Knowledge of Japan and International cGMP, regulatory and company’s global requirement in pharmaceutical Operations.
Knowledge about QA & QC
Analytical and strong logical orientation
Networking and collaboration across the organization, Skills for Effective communication and leadership.
Qualifications:
M.Sc / M.Pharm / MS / Ph.D / B.Pharm
Any other requirements of the job
15 to 20 years total experience in the Pharmaceutical Industry out of which at least 8 to 10 years should be in Quality Function and rest in one more department like manufacturing or formulation development or analytical development
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1,000 ~ 1,550万円
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
...
PurposeTo implement and monitor Quality Management System for products manufactured by CMOs for EM Japan, to ensure the compliance as per cGMP and applicable Global quality standards.Performance Standards: Duties & Responsibilities1.Change Control Management: 18%Manage Change controls received from CMO and EM Japan cross-functions through global database (example Phenix ) as per requirements of global quality standards and procedures and local SOP with the assistance from Team support executives. Coordinate with Quality manager/ CMO managers (if required) for Quality evaluation of CC , assign CC to regulatory team for the regulatory evaluation Approve/reject the CC request with assignment of work plan where applicable Follow up on implementation of work plan by respective work-leaders and approve and close the CC in global database Maintain and report monthly KPI for the CC.2.Events and CAPA Management: 10%Manage Events/deviations/incidents/OOS/OOT received from CMO and EM Japan cross-functions through global database (example Phenix ) as per global quality standards and procedures and local SOP, with the assistance from Team support executives. Coordinate with Area responsible manager for acceptance or rejections of deviation, follow up for the completed deviation/OOS/OOT report. Define & assign appropriate CAPA /tasks where required to respective Quality manager for execution. Approve and close the deviation/OOS/OOT in global database( example Phenix) & Maintain and report monthly KPI , for the Events and CAPA3.Quality Risk Management: 5%Manage and raise risk for the appropriate events in global database as per requirements of global quality standards and procedures by aligning discussion with the Head QO and Head EM. Ensure completion of investigation reports by respective Quality manager Circulate RQN as per Global distribution list , Arrange Quality Alert meeting with Global stakeholders, prepare circulate MOM. Update the appropriate action plan on timely manner in global database . Conduct quarterly risk review meeting with global quality alert manager Maintain and report monthly KPI for risks reported in global database4. Market complaints: 5%Ensure market complaints are managed as per requirements of global quality standards and procedures Ensure communication of Market complaint to respective Quality manager , completion of investigations and closure in timely manner unless justified with documentation . Ensure CAPA are in place wherever required. Trend analysis of market complaint as per SOP. Maintain and report monthly KPI for the market complaint.5. In place In use Management: 10%Implement “In Place In Use” Programme for Global Quality Standards and procedures applicable for EM Japan Define the implementation plan – for the updated applicable standards , do the gap assessment as per the defined IPIU programme Maintain and report monthly KPI for IN place in Use program.6.QSTP alerts: 2.5%Assess the impact of QSTP alerts received from the Global on EM Japan portfolio. Coordinate with Quality manager and by discussion with head QO, for risk assessment ,assign respective CAPA to Quality managers for the implementation. Response to Global QSTP team for the action plan and its status in case of alerts.7. Document Management (Geode+) : 10%Coordinate with TSEs and Quality manager and ensure maintenance of GMP documents in Geode + for EM Japan with proper documental approval flow Maintain and revise EM SOP as per the schedule. Coordinate with TSEs and Quality manager , maintain and revise Specification RM/FP as per the schedule. Approve the documents in Geode+.8.Training : 10%Prepare and maintain training schedule for EM Japan Quality team. Identify the Training needs for the EM Team and plan training for the same. Schedule training as per the Training calendar. Maintain and report monthly KPI for training.9.QTP Database : 2.5%Coordinate with team support executive and ensure maintenance and periodic updation of QTP( QualityThird Party ) data in global database system ( example phenix )10.Audit Readiness: 10%Participate and execute the Audit readiness tool as per requirements of Global Quality by discussion with Quality managers.11.Project Management: 10%Support and execute for the project assigned as per EM Japan project management team. (Risk assessment , Quality agreement QSMP with reporting of monthly KPI )12.cGMP Audit: 7%Plan and execute the GMP audit assigned as per Audit calendar.
求められる経験
Pre-requisites:
Knowledge, Skills & Competencies / Language
Sound Knowledge of Japan and International cGMP, regulatory and company’s global requirement in pharmaceutical Operations.
Knowledge about QA & QC
Analytical and strong logical orientation
Networking and collaboration across the organization, Skills for Effective communication and leadership.
Qualifications:
M.Sc / M.Pharm / MS / Ph.D / B.Pharm
Any other requirements of the job
15 to 20 years total experience in the Pharmaceutical Industry out of which at least 8 to 10 years should be in Quality Function and rest in one more department like manufacturing or formulation development or analytical development
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1,000 ~ 1,550万円
賞与
-
show more