募集要項
- 募集背景
-
Hiring background：
In order to realize "Continuous Creation of Life-Changing Value" as stated in our Vision 2030 announced in February 2024, we have decided to integrate the APAC region into the JP region as of January 1, 2025 as "Story for Vision 2030. We must continue our quality assurance activities and contribute to patients.
- 仕事内容
-
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:Key Responsibilities：
- 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.
- 応募資格
-
- 必須
-
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.
- 募集年齢(年齢制限理由)
- 35 Years Old ～ 40 Years Old (as guideline) （特定年齢層の特定職種の労働者が相当程度少ないため）
- フィットする人物像
-
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.
- 雇用形態
-
Full-time employee
*6 month trial period
- ポジション・役割
- Quality Headquarters, Quality Assurance Department/ Staff or Manager
- 勤務地
- Tokyo (Chiyoda-ku)
- 勤務時間
-
A super flextime system: Working hours: 3-hours between 7:00 and 20:00 (no core time, working hours: 7 hours 40 minutes)
*Remote work available: Guideline: Coming to the office 1-3 days a week. Full remote work is not currently possible.)
- 年収・給与
- 6.5 million yen ～ 13.99 million yen
- 待遇・福利厚生
-
Benefits: Social insurance (health insurance, nursing care insurance, employee pension insurance, employment insurance, workers' compensation insurance), various savings plans, residential sub-lending loan plan, 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 for marriage and childbirth, family support allowance, return employment system
*Smoking is completely prohibited in the company
*There are also systems for shortened working hours for childcare and shortened working hours for nursing care.
- 休日休暇
-
Sundays, national holidays, Saturdays, New Year's holiday (12/29-1/3), 125 days off per year, 2 days off per week
Paid leave: 15-20 days depending on years of service
Other: Comprehensive systems for spousal maternity leave, maternity leave, and childcare leave.
- 選考プロセス
-
Document screening ⇒ 1st interview ⇒ SPI aptitude test ⇒ Final interview (including English interview)
The interview will be held at the head office (Otemachi, Chiyoda-ku, Tokyo).
Travel expenses will be reimbursed.
*If you come by personal car, you will not be reimbursed.
*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).
