Johnson & Johnson キャリア


千代田区, 日本
Quality Assurance


Requisition ID: 1700190501W

<Responsibilities include, but not limited to:>
  • Ensure consistency of the manufacturing, specifications and test methods with the registered dossiers in Japan.
  • Lead corrective and preventive actions to maintain compliance status with the registered dossiers in Japan.
  • Maintain Quality Agreement with External Manufactures, Contract Laboratories and Logistic Service Providers as needed
  • Contribute to the BQ mission, vision and strategy
  • Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
  • Support GxP system (CAPA, Change Control, Deviation, Quality issue, Training etc.)
  • Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.
  • Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
  • Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.
  • Conduct regular (self-) inspections that are applicable on the supply chain within the responsibilities of the LOC.
  • Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.


<Work Experience>

  • +7 years of directly related experience in quality assurance and quality related activities., or Johnson & Johnson
  • Experience with Japanese pharmaceutical companies

<Necessary Skills>

  • Excellent communication skills both in English and Japanese
  • Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
  • Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
  • Project management skill
  • Advanced degree (MS, MBA, PhD) preferred
it is preferred
  • Have experience in manufacturing, product quality, CMC, RA or GXP audit
  • Have a pharmacist’s license
  • Leadership to challenge the status quo and how things have always been done.
  • Leadership and 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 even in a new work area.
  • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders

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