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
...
Job Description:This position is the main Quality contact in Japan and will have strong experience in GxP’s, GQP and Quality Management Systems (QMS) and will have worked in an global Quality environment. This role will lead the implementation and execution of the local and Enterprise Quality System (SOP’s and Technology) and support compliance to current regulations, procedures and standards across the business.They will be a key commercial business partner for Japan and the General Manager and will collaborate cross functionally for new product launches, changes in the QMS and lead cross functional collaboration.They will have suitable qualifications and experience to act as the Soseki in order to provide strong representation and leadership to the company's leadership team.They will lead local the Quality team to ensure product and/or service is consistent and meets the requirements and established standards. This includes performing and managing tasks associated with GQP for production and quality control and GMP for investigational new drug for developing items.Lead and have experience in Quality discussions with Regulators, Tokyo Health Authority, PMDA etc. as required.Responsibility- Ensure on-going compliance to company’s global quality and compliance systems, and associated procedures and standards at the site level.- Ensure that company Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with local guidelines.- Act as Soseki to ensure Quality and Safety issues are reviewed, escalated and guidance provided to the General Manager (optional)- Provide internal auditing resource to assess site compliance on a regular basis- Manage the review and implementation of Quality Improvement/remediation plans for site identified through Corporate, internal or Health Authority inspections- Support local/regional Quality activities- Monitor GMP, GQP and GDP compliance to local regulations and the company’s proceduresPartn- er with local, regional and global operational groups to foster a proactive approach to compliance.- Create partnerships with Japanese contractors and work with the global team to manage and monitor performance- Ensuring that the quality management system (QMS) is maintained and assist in the implementation of Enterprise processes and includes but not limited to;DeviationCorrective Action Preventative Action (CAPA)Complaint ManagementChange ControlDocumentationTrainingRecallSelf-InspectionQuality Risk ManagementQuality Management Review- Ensure that accurate quality records are maintained in support of Data Integrity- Ensure appropriate local QMS training is implemented and tracked across the organization- Maintain quality agreements with suppliers/distributor/wholesaler and global.- Support the Japanese Regulatory Affairs function with the;a. Clinical products import,b. Submission of GMP documents to PMDA, including, but not limited to;– PMDA GMP clearances and– GMP inspection applications on a PCA- Assist in the coordination of recalls, registration and processing of customer complaints, reconciliation.- Work closely with Supply Chain, Regulatory affairs, PV to ensure compliance and support for the business.
求められる経験
Requirements
- 10+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Registered Pharmacist is preferred for the role of Marketing Supervisor-general (Soseki) (optional)
- Thorough knowledge of CMC science such as the process validation, QC testing and so on
- Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Exceptional communication and interpersonal skills to cultivate the good relation with the business partners such as CMO, analytical labs and so on.
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収1,600 ～ 1,900万円
賞与
-
雇用期間
期間の定めなし
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
...
Job Description:This position is the main Quality contact in Japan and will have strong experience in GxP’s, GQP and Quality Management Systems (QMS) and will have worked in an global Quality environment. This role will lead the implementation and execution of the local and Enterprise Quality System (SOP’s and Technology) and support compliance to current regulations, procedures and standards across the business.They will be a key commercial business partner for Japan and the General Manager and will collaborate cross functionally for new product launches, changes in the QMS and lead cross functional collaboration.They will have suitable qualifications and experience to act as the Soseki in order to provide strong representation and leadership to the company's leadership team.They will lead local the Quality team to ensure product and/or service is consistent and meets the requirements and established standards. This includes performing and managing tasks associated with GQP for production and quality control and GMP for investigational new drug for developing items.Lead and have experience in Quality discussions with Regulators, Tokyo Health Authority, PMDA etc. as required.Responsibility- Ensure on-going compliance to company’s global quality and compliance systems, and associated procedures and standards at the site level.- Ensure that company Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with local guidelines.- Act as Soseki to ensure Quality and Safety issues are reviewed, escalated and guidance provided to the General Manager (optional)- Provide internal auditing resource to assess site compliance on a regular basis- Manage the review and implementation of Quality Improvement/remediation plans for site identified through Corporate, internal or Health Authority inspections- Support local/regional Quality activities- Monitor GMP, GQP and GDP compliance to local regulations and the company’s proceduresPartn- er with local, regional and global operational groups to foster a proactive approach to compliance.- Create partnerships with Japanese contractors and work with the global team to manage and monitor performance- Ensuring that the quality management system (QMS) is maintained and assist in the implementation of Enterprise processes and includes but not limited to;DeviationCorrective Action Preventative Action (CAPA)Complaint ManagementChange ControlDocumentationTrainingRecallSelf-InspectionQuality Risk ManagementQuality Management Review- Ensure that accurate quality records are maintained in support of Data Integrity- Ensure appropriate local QMS training is implemented and tracked across the organization- Maintain quality agreements with suppliers/distributor/wholesaler and global.- Support the Japanese Regulatory Affairs function with the;a. Clinical products import,b. Submission of GMP documents to PMDA, including, but not limited to;– PMDA GMP clearances and– GMP inspection applications on a PCA- Assist in the coordination of recalls, registration and processing of customer complaints, reconciliation.- Work closely with Supply Chain, Regulatory affairs, PV to ensure compliance and support for the business.
求められる経験
Requirements
- 10+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Registered Pharmacist is preferred for the role of Marketing Supervisor-general (Soseki) (optional)
- Thorough knowledge of CMC science such as the process validation, QC testing and so on
- Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Exceptional communication and interpersonal skills to cultivate the good relation with the business partners such as CMO, analytical labs and so on.
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収1,600 ～ 1,900万円
賞与
-
雇用期間
期間の定めなし
show more
