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Updated 2020-11-15
Activated 2020-11-15

CMC Research Position-Quality Assurance and Analytical Research for Investigational Drug GMP

  • ★★★ Senior Level
  • Women Welcome
  • New graduates welcome
  • Listed Public Company
  • No Experience Required
This posting is managed by:
Recruiter
j Career Co.,Ltd. / 株式会社 j Career
Company Name Company is not publicly visible
Job Type
j Career Co.,Ltd. / 株式会社 j Career
Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC
Medical/Pharmaceutical/Bio/Fabric/Food - Research
Medical/Pharmaceutical/Bio/Fabric/Food - Valuation/Testing
Industry Pharmaceuticals
Location Asia Japan Tokushima
Asia Japan Saitama
Job Description ① CMC research position (quality assurance of investigational drug GMP) *Supervisor/manager*
1. Quality assurance and reliability assurance of investigational drug GMP, PIC/S, data and materials in accordance with internal regulations
2. Inspecting regulatory authorities and affiliated facilities (Tokushima, Saitama)
3.Outsource contractors/partners, Vendor audits of raw materials and additives, and continuous guidance (raw materials, drug products)
4. Management and transmission of quality-related documents

② CMC research position (analytical research) * Managerial position / candidate for managerial position *
・Obtained manufacturing and marketing approval in Japan and overseas (formulation quality related)
・As the second response department for inquiries about product information from users, respond to matters related to formulation quality and provide information.
・Measurement of physical properties of drug product for development stage and approval application
・Establishment of drug product specifications and test methods for the development stage and application for approval, and implementation of stability tests
・Verification of consistency and equivalence of drug product quality from clinical development to market launch
・Transfer analysis technology to production department
・Support for CTM room in quality testing of investigational drugs
・Submit/update information to regulatory authorities for domestic and overseas clinical trials (formulation quality related)
・Flexible and appropriate quality assurance of investigational drug according to the country and stage of development
Company Info We are energetically promoting research and development of highly novel medicines such as anti-cancer agents, immune/allergy, and urological medicines. In particular, in recent years, in order to quickly deliver our own drugs to patients around the world and to maintain their quality, we have established a global pharmaceutical affairs strategy and are applying, approving, and maintaining drugs.

[Measures to prevent second-hand smoke]
Indoor smoking ban (with smoking room)
Working Hours ① CMC researcher (Quality assurance of investigational drug GMP)
8:00-17:00 (Tokushima), 8:30-17:30 (Saitama)

② CMC researcher (analytical research)
8:00~17:00
Job
Requirements
① CMC research position (quality assurance of investigational drug GMP) *Supervisor/manager*
[Required (MUST)]
・Quality assurance, quality control, and manufacturing control business in pharmaceutical or investigational drug manufacturing (3 years or more)
・Person who has experience of conducting inspections in Japan or overseas
・Knowledge about drug and investigational drug regulations in the three regions (Japan, US, and Europe) such as the Pharmacopoeia Law (GCP, GMP, QMS Ministerial Ordinance), EMA and FDA
[WELCOME]
・Knowledge about pharmaceutical manufacturing technology and pharmaceutical affairs (application for approval)
<Desirable figure>
・ Those who have fact-based analysis, judgment, and understanding
・Person who has interpersonal adjustment ability and can build a good relationship with internal and external parties
・Persons who can work on their own initiative and can make their own decisions
・Those who have strategic and logical thinking skills
・Stress resistant and capable of responding to new work environments

② CMC research position (analytical research) * Managerial position / candidate for managerial position *
[Required (MUST)]
・Experience in analysis and management of investigational drug (or investigational drug substance)
・Global clinical trial application or approval application document preparation and response to inquiries
[WELCOME]
・Knowledge about pharmaceutical manufacturing technology and pharmaceutical affairs (application for approval)
・Improvement of various in-house procedures/work flow
・ Those who have fact-based analysis, judgment, and understanding
・Person who has interpersonal adjustment ability and can build a good relationship with internal and external parties
・Persons who can work on their own initiative and can make their own decisions
・Those who have strategic and logical thinking skills
・Stress resistant and capable of responding to new work environments
Japanese Level Business Level(JLPT Level 2 or N2)
Salary JPY - Japanese Yen JPY 4000K - JPY 5000K   
Other Salary
Description
Basic salary 300,000 to 350,000 yen/month, with bonus
Holidays Sundays, public holidays, year-end and New Year holidays, company-designated holidays
Job Contract
Period
Contract period: 6 months or 1 year (after that, it is assumed that full-time employees will be appointed)
Trial period: None
Nearest Station ① CMC researcher (quality assurance of investigational drug GMP): Tokushima prefecture or Saitama prefecture
② CMC researcher (analytical research): Tokushima Prefecture

◆ Tokushima City
・From Tokushima Airport
8 minutes by bus, 10 minutes on foot
・From Tokushima Station
15 minutes by bus, 10 minutes on foot

◆Kodama-gun, Saitama Prefecture
・20 minutes by taxi from Honjo Station on the JR Takasaki Line
・10 minutes by taxi from JR Joetsu Shinkansen Honjo Waseda Station
・10 minutes by taxi from Kodama Station on the JR Hachiko Line
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j Career Co.,Ltd. / 株式会社 j Career

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CMC Research Position-Quality Assurance and Analytical Research for Investigational Drug GMP

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