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  3. Snr Specialist/Specialist Quality Operations

Snr Specialist/Specialist Quality Operations

600 〜 1000 ten thousand JPY

  • RGF HR Agent
  • Location: Other parts of Japan
  • 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
Senior Specialist or Specialist Quality Operations - Top Global Mega Pharma Company

Job Description
Position Overview – Basic Functions & Responsibility

This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with our requirements and regulatory requirements and expectations.

Under his/her responsibilities fall the quality oversight for

- Receipt, handling, storage, and disposition of products and components
- Batch record review and Release
- Deviation investigations
- Corrective and preventive actions (CAPA) investigation, management and approval

The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Operations Manager) with regards to the above described activities.
The role has newly formed with organizational changes, thus shifting of responsibilities in near future is acceptable.

Primary Activities
1. Establish adequate controls and procedures for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labeling, drug substances incl. intermediates and drug products incl. intermediates.
2. Ensure that adequate processes and procedures are in place and followed for batch record review.
3. Participate and/or Lead investigations with collaboration of other departments, generate deviation reports, perform trend analysis of root causes on a periodic basis.
4. Manage corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labeling, drug substances and drug products and associated facilities.
5. Perform Annual Product Reviews/Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
6. Represent quality, provide quality oversight in complex projects or initiatives such as new product introduction.
7. Participate in continuous improvement initiatives and be act as a change agent to initiate such activities

Requirements
Skills
• Degree in Life Sciences, Engineering or related relevant discipline.
• Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
• Knowledgeable of Japanese and global authority quality and compliance requirements
• Knowledgeable in Industry Best Practices for quality and compliance related topics.
• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
• Preferably have project management skills.
• Be ready to act as change agent
• Good Japanese and English communication skills (TOEIC 750 or more)

About interview

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Name of person in charge of hiring:

Snr Specialist/Specialist Quality Operations

RGF HR Agent

600 〜 1000 ten thousand JPY

Close

Company overview

RGF HR Agent Snr Specialist/Specialist Quality Operations RGF HR Agent Snr Specialist/Specialist Quality Operations

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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