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  3. Specialist, Quality Systems & Compliance

Specialist, Quality Systems & Compliance

500 〜 900 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:Fluent │Required length of experience:Uncategorized
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Date:2020/01/22~2020/07/20

Job summary

Job category Technical (Sales / Design / Development / Production Control)/Production Control / Quality Control / Construction Control / Environment, Health, and Safety / Postmarketing Surveillance
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

Japanese (Fluent)

English (Business)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
Quality Systems & Compliance Specialist - Top Global Mega Pharma

Job Description
【職務内容】

製造販売業者の品質保証業務における以下の業務:
・ 国内外の規制要件や米国本社のポリシー、ガイドラインに基づき、レギュラトリ―サポート業務を行う。
・ 外国製造業者認定の新規申請・維持管理業務を行う。
・ 国内外の製造業者のGMP適合性調査申請業務を行う(指摘事項対応のサポートを含む)。
・ 製造業者、薬事部門と協働し、製造販売承認申請書と製造実態との定期的な照合(定期点検)業務を行う。
・ 上記関連業務の手順書を作成・整備・維持する。
・ 上記の主な担当業務以外に、GQP業務全般のサポートを行うこともある

Job Description:

Quality Assurance activities of the Marketing Authorization Holder as described below:
・ Assures regulatory support activities operate within established policies/procedures, company requirements, and all applicable governmental regulations (GMP, etc.).
・ Supports foreign site accreditation application and maintenance activities to support new product launches and changes.
・ Support GMP compliance inspections of foreign and domestic manufacturers (to include support for remediation of GMP gaps)
・ In collaboration with Manufacturers and Regulatory functions, support the conformance reviews of site practices against the marketing authorizations.
・ Establish and maintain local procedures for above activities.
・ In addition to above activities, also support Quality Assurance activities as defined in the GQP Regulations.

Requirements
【資格要件】

・ 生物学、微生物学、薬学、化学、化学工学、またはそれと同等の学位を持っていることが望ましい。
・ 品質保証、品質管理に関する深い知識と幅広い経験。
・ 日本語/英語による優れたコミュニケーションスキル。
・ 人脈形成スキル、ステークホルダーと適切な関係を構築するスキル。
・ 国内外の薬事規制、公定書等に精通していること。
・ 非ルーチン、多様な文化の中での業務を扱うための対人能力と強力なリーダーシップスキル。
・ ある程度のファイナンスに関する知識。

Qualifications:

・ BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
・ Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities.
・ Must have strong demonstrated communication skills in Japanese and English.
・ Must be conversant with applicable regulations and compendia governing operations.
・ Some level of contractual and financial awareness is required.
・ Strong interpersonal and leadership skills in dealing with a broad variety of cultures on non-routine matters.
・ Must have demonstrated personal networking and relationship skills.

About interview

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Name of person in charge of hiring:

Specialist, Quality Systems & Compliance

RGF HR Agent

500 〜 900 ten thousand JPY

Close

Company overview

RGF HR Agent Specialist, Quality Systems & Compliance RGF HR Agent Specialist, Quality Systems & Compliance

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

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