社名
社名非公開
職種
品質保証、品質管理
業務内容
...
Scope: QA Senior Specialist works with QA Manager, or In-Country Quality Operations Manager of the first-class Medical Device Market Authorization Holder to perform quality assurance duties defined by Pharmaceutical and Medical Device Act and regulations appropriately and in smooth. Job Summary: •In accordance with QMS ordinance, QA Senior Specialist performs manufacturing & quality control duties in smooth and appropriately. •QA Senior Specialist plans improvement and resolves quality issues with cooperation of Manufacturing sites & Distribution Centers. •QA Senior Specialist manages applications and renewals of the licenses necessary for maintaining the business condition of marketing authorization. Essential Functions & Accountabilities: • QMS Compliance ・ Establish or revise Quality Assurance Procedures / Standard Operating Procedures required by QMS ordinance. ・ Implement the requirements required by QMS Ordinance, and maintain and operate CVJ's QMS. ・ Evaluate the results of manufacturing & quality controls appropriately and decide market release of the products. ・ Evaluate and verify that foreign manufacturers perform manufacturing & quality controls appropriately. ・ Manage and assess changes at the manufacturers. •Quality improvement & recalls ・ Plan to improve quality with cooperation of foreign manufacturers and complaint handling. ・ Plan to propose countermeasures to recalls and to provide information for the cases where quality issues are occurred. ・ For the cases requiring recalls, to coordinate the recall with local regulatory agency to initiate and close them. ■Job Description •Regulatory establishment ・ Submit applications of license or for renewal necessary for maintaining business condition of market authorization. ・ Correspond to QMS conformity inspection on foreign manufacturers and registration on foreign manufacturers. ・ Others ・ Support for assuring quality of investigational devices for use in clinical studies and control of in & out of investigational devices. ・ Perform supplier audits not only for local purpose but only for global perspectives. ・ Support for global eQMS as local admin. Travel: •International: 5% = Max. 3 weeks per year Visit manufacturing sites for quality check and/or meetings if necessary. •Domestic: 5% = Approx. 3 weeks per year Visit OEM products supply customers for regular meetings. Visit material suppliers located in Japan to support supplier audits controlled by global QMS. Work Environment: •Normal office setting with desk/chair and PC. •Flexible job setting including flex time rule and hybrid work. • Travel on an ad-hoc basis.
求められる経験
Qualifications:
Knowledge, Skills, Mindset and Abilities:
•Good interpersonal skills to build up a good relationship with both internal (other function including manufacture sites) and external (government) stakeholders.
•Knowledge of the law and regulation relevant to QMS.
•Preferable to have an experience in foreign affiliated companies where English communication takes place on a daily basis.
•Have an experience in communicating global RAQA team and foreign Mfg sites & DCs as a plus.
•Intermediate skills in the use of Excel, Word and PowerPoint.
•Collaboration/respect-each-other mindset in a friendly way for effective business partnering. • Strong sense of compliance as a QA professional.
Experience:
•Enough knowledge and experience of Quality Assurance in pharmaceutical or medical device company.
•Minimum 5 years of experience of Quality Assurance in pharmaceutical or medical device company, including corresponding to on-site inspection by PMDA and Tokyo Metropolitan Government.
•Experience in Quality Management Systems, ISO13485 and MDSAP.
Education:
•Bachelor’s degree in a scientific or technical discipline and working knowledge of pharmaceutical or medical device regulations.
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収800 ～ 1,200万円
賞与
-
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
品質保証、品質管理
業務内容
...
Scope: QA Senior Specialist works with QA Manager, or In-Country Quality Operations Manager of the first-class Medical Device Market Authorization Holder to perform quality assurance duties defined by Pharmaceutical and Medical Device Act and regulations appropriately and in smooth. Job Summary: •In accordance with QMS ordinance, QA Senior Specialist performs manufacturing & quality control duties in smooth and appropriately. •QA Senior Specialist plans improvement and resolves quality issues with cooperation of Manufacturing sites & Distribution Centers. •QA Senior Specialist manages applications and renewals of the licenses necessary for maintaining the business condition of marketing authorization. Essential Functions & Accountabilities: • QMS Compliance ・ Establish or revise Quality Assurance Procedures / Standard Operating Procedures required by QMS ordinance. ・ Implement the requirements required by QMS Ordinance, and maintain and operate CVJ's QMS. ・ Evaluate the results of manufacturing & quality controls appropriately and decide market release of the products. ・ Evaluate and verify that foreign manufacturers perform manufacturing & quality controls appropriately. ・ Manage and assess changes at the manufacturers. •Quality improvement & recalls ・ Plan to improve quality with cooperation of foreign manufacturers and complaint handling. ・ Plan to propose countermeasures to recalls and to provide information for the cases where quality issues are occurred. ・ For the cases requiring recalls, to coordinate the recall with local regulatory agency to initiate and close them. ■Job Description •Regulatory establishment ・ Submit applications of license or for renewal necessary for maintaining business condition of market authorization. ・ Correspond to QMS conformity inspection on foreign manufacturers and registration on foreign manufacturers. ・ Others ・ Support for assuring quality of investigational devices for use in clinical studies and control of in & out of investigational devices. ・ Perform supplier audits not only for local purpose but only for global perspectives. ・ Support for global eQMS as local admin. Travel: •International: 5% = Max. 3 weeks per year Visit manufacturing sites for quality check and/or meetings if necessary. •Domestic: 5% = Approx. 3 weeks per year Visit OEM products supply customers for regular meetings. Visit material suppliers located in Japan to support supplier audits controlled by global QMS. Work Environment: •Normal office setting with desk/chair and PC. •Flexible job setting including flex time rule and hybrid work. • Travel on an ad-hoc basis.
求められる経験
Qualifications:
Knowledge, Skills, Mindset and Abilities:
•Good interpersonal skills to build up a good relationship with both internal (other function including manufacture sites) and external (government) stakeholders.
•Knowledge of the law and regulation relevant to QMS.
•Preferable to have an experience in foreign affiliated companies where English communication takes place on a daily basis.
•Have an experience in communicating global RAQA team and foreign Mfg sites & DCs as a plus.
•Intermediate skills in the use of Excel, Word and PowerPoint.
•Collaboration/respect-each-other mindset in a friendly way for effective business partnering. • Strong sense of compliance as a QA professional.
Experience:
•Enough knowledge and experience of Quality Assurance in pharmaceutical or medical device company.
•Minimum 5 years of experience of Quality Assurance in pharmaceutical or medical device company, including corresponding to on-site inspection by PMDA and Tokyo Metropolitan Government.
•Experience in Quality Management Systems, ISO13485 and MDSAP.
Education:
•Bachelor’s degree in a scientific or technical discipline and working knowledge of pharmaceutical or medical device regulations.
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収800 ～ 1,200万円
賞与
-
雇用期間
期間の定めなし
show more
