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Johnson & Johnson キャリア

【Janssen】GQP/GMP Training & Document Control Senior Specialist

千代田区, 日本
Quality Assurance


仕事内容

Requisition ID: 1805695834W

Overall purpose of job:

This role aims to support key compliance requirements for GQP ordinance in Japan and J&J global standards for Business Quality (BQ). The role will help ensure there is appropriate Marketing Authorization Holder (MAH) oversight of all supplying manufacturers to Japan local operating company.

 

Essential duties and responsibilities:

Responsibilities include, but not limited to:

  1. Develop and drive improvement in Training and/or Document Control related to GQP as well as management of Quality issue and CAPA.
  • Identify, develop and deliver GMP training for manufacturing sites in terms of MAH.
  • Make a gap analysis of regulation changes and lead introduction of the changes to Janssen Pharmaceutical K.K. (Janssen Japan).  Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GQP/GMP, product testing and Japanese Pharmacopoeia requirements
  • Supports Quality System Management Review for Janssen Japan, providing in-depth data analysis of product information including complaint data.
  • Identification and leadership of tactical continuous improvement opportunities
  • Active engagement with Health Authority bodies, including performing lead and support roles as required for Janssen Japan during internal audits, JJRC Audits and external inspections.
  • Provide leadership, oversight and strategic guidance for significant regulatory compliance issues of Janssen Japan
  • Partner on the formulation of responses to JJRC and Health Authority bodies in order to address QMS related observations.  Collaborate on the identification and implementation of corrective actions.  Ensure effective and timely completion of all corrective actions and related commitments.
  • Japan BQ lead for the deployment of QS Enterprise standards, cross-sector and pharma sector SOPs.
  • Ensure emerging regulatory requirements are addressed in a proactive and effective manner
  • Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings.  
  • Support BQ objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure
  • Contribute to the BQ mission, vision and strategy


資格
  • Special requirements:
  • +2 years of directly related experience in quality assurance and quality related activities.
  • Preferably with basic knowledge in manufacturing process, problem solving/investigation tools, product quality and GxP audits
  • Demonstrated ability to manage relationship, development and maintenance, and negotiation skills.
  •  

  • Other features of the job:

  • N/A
  • Job location:
  • J&J Tokyo Head Office, Japan
  •  
  • Job Requirements
  • Essential knowledge and skills:

    • Experience with Japanese pharmaceutical companies
    • Good communication skills both in English and Japanese
    • Good verbal and written communications skills. Must be able to effectively articulate ideas with different levels in the organization.
    • Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
    • Project management skill
     

    Core competencies required for this role:

    • Leadership as an individual contributor to challenge the status quo and how things have always been done.
    • Motivation with high personal integrity and application of J&J Credo Values in daily operations.
    • Leadership experience leading projects, programs or other global initiatives
    • Can show his/her agility, ability to learn fast and comfort in complex environment.
    • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholder


プライマリ場所
日本-東京都-千代田区-
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Quality Assurance
Requisition ID
1805695834W