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[Remote work AVL] JAPAC MAH QA Manager／Specialist

年収：1000万 ～ 1400万

ヘッドハンター案件

部署・役職名 [Remote work AVL] JAPAC MAH QA Manager／Specialist
職種
業種
勤務地
仕事内容 Key Responsibilities：
As the MAH （Marketing Authorization Holder） in the JAPAC （Japan and Asia Pacific） region, you will be responsible for managing the following Quality Assurance （QA） activities:
－ Provide advice on QA tasks based on experience.
－ Communicate with health authorities and respond to inquiries. Coordinate NDA/sNDA/GMP clearance and other documents.
－ Takeover of monitoring of distributors, compliance and repackaging instruction review and approval. Supplier quality management, QA artwork tasks. System administration / BPL activities of eQMS.
－ Communication with distributors, GMP/GDP compliance activities （changes, deviations, shipments, inspections）. Monthly reporting and metrics, internal audit and inspection. Quality agreement with our subsidiaries, partners and distributors.
－ Other tasks related to their organization or function that are reasonably necessary, as well as organizational skills development （human resource training and organizational development）.

Job Purpose：
－ We are committed to taking a leap forward to become a global specialty pharmaceutical company.
－ As a QA manager/specialist, an opportunity will be provided to experience a wide range of global QA operations and to cultivate global communication skills.
－ The smooth continuation of global operations is also a very important activity to maximize the value of global products to achieve the Story for Our Vision 2030.
－ Can contribute to product quality assurance for the benefit of patients globaly.
労働条件 Full－time employee, with 6 month trial period
position＆roles：Quality Headquarters, Quality Assurance Department/ Staff or Manager

Work location: Head office （Chiyoda－ku, Tokyo）
Working hours: ＊Super flex system implemented.
Work 3 hours between 7:00 and 20:00 （no core time, regular working hours: 7 hours 40 minutes）
＊Hybrid work is promoted: Come to the office 1－3 days a week. Full remote work is not currently possible.
＊Other systems are available for short－time work for childcare and short－time work for elderly care.

Expected annual salary （guideline）: 6.5 million to 14 million yen
＊Annual salary will be considered based on the individual's age, ability, experience, and duties.

Benefits and welfare:
Benefits: Social insurance （health insurance, nursing care insurance, employee pension insurance, employment insurance, workers' compensation insurance）, various savings plans, residential loan system, group welfare association, corporate pension, defined contribution pension, welfare services, various group insurance
Other: Housing subsidy, babysitter subsidy, nursing care leave, leave due to spouse's transfer, MR cohabitation support system at marriage and childbirth, family support allowance, return employment system
＊Certified for 8 consecutive years since the establishment of the METI ”Health and Productivity Management Excellent Corporation 2024 （White 500）” system.

Holidays and holidays:
Sundays, holidays, Saturdays, New Year's holidays （12/29－1/3）, 125 days of holidays per year, 2 days off per week
Paid leave: 15－20 days depending on years of service,
Other: Spousal maternity leave, maternity leave before and after childbirth, and childcare leave systems are available.

Selection process: Document screening ⇒ First interview ⇒ SPI aptitude test ⇒ Final interview
＊An English CV is required for application.
＊Interviews may be conducted in English.
＊Interviews will be conducted at the head office （Tokyo）.
＊For the time being, online interviews may be conducted.

Note:
[Clarification in accordance with the amendment to the Enforcement Regulations of the Employment Security Law （effective April 1, 2024）]
1. Scope of changes in work to be performed: You may be ordered to perform all work within the company.
2. Scope of changes in place of work: You may be ordered to transfer to all of our business locations and to other companies, corporations, or organizations （including places where you can work from home） as secondments or dispatches. Places where you can work from home include your own home, your own or your spouse's parents' home, or your spouse's home （however, working from home is only permitted if the company approves it）.
応募資格

【必須（MUST）】

Position Requirements：
－ Basic expertise in Post Approval Quality Assurance is required.
－ GMP Experience is required （at least 3 years, on QA/QC/Manufacturing）.
－ Sufficient knowledge and practical experience in pharmaceutical applications is desirable.
－ Requires an understanding of the latest developments in GMP/GDP/GQP/Related regulations.
－ Learning to develop an understanding of the manufacturing processes of our key products is recommended.

Language Skills：
－ Negotiation and consensus－building English language skills required.
－ Continuous improvement of Japanese skills is required.

Type of people who would be a good fit:
－ Communication and coordination skills to build good relationships with stakeholders and related parties to drive operations, and willingness and negotiation skills to face individual cases are required.
[Essential requirement] Nonsmoker
・Our Group strives for Health ＆ Productivity Management aiming to “deliver good health, quality and well－being in each employee’s life.” We would like to request all the applicants for our mid－career recruitment to observe the above ”Essential requirement”. We would appreciate your kind understanding.
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更新日 2024/09/24
求人番号 3770757

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