[Quality/Consumer]Business Quality Specialist

Johnson & Johnson (Chiyoda, 日本) 20日前

Position Summary

The BQ Specialist is responsible for Dr.Ci:Labo (DCL) quality operation in J&J Consumer Health Japan as primary role. This includes both Quality Management System (QMS) and Product (Franchise) Quality for ensuring compliance to the applicable regulation (GQP/GMP/QMS and/or Food regulation) and J&J policy, standard & procedures.

The incumbent will report either Manager/Associate Director in J&J Japan LOC or DCL LOC.

This position will manage OTC GQP or Food Quality Assurance as secondary role.

The incumbent is a potential successor of GMP Pharmacist or GQP Quality Assurance Supervisor for OTC, etc.

Job Description – Basic Role and Responsibility

  • Manage DCL QMS establishment projects, Product compliance review, J&J system integration, talent capability building, etc.
  • Manage Good Distribution Practice (GDP) in the market specially for drug (OTC) product.
  • Implements new product launch readiness including quality deliverables and GMP inspection (paper and on-site).
  • Maintains J&J Quality Policy and Standards aligned with GQP and Pharmaceutical and Medical Devise Act (PMD Act) - products may include OTC, Quasi-Drug, Cosmetic, Type I Medical Device and Food.
  • Maintain Quality Assurance of Food with local Food regulation.
  • Contributes to the J&J mission, vision and strategy.
  • Implements GxP system based on J&J Standard and GQP, such as Batch Release, Change control, Deviation and Non-conformance (NC), CAPA, GMP Audit, Supplier Qualification, Self-inspection, Training, Product Quality Complaint, Recall, etc to maintain Quality and Regulatory compliance.
  • Maintain good relationship with cross-functional team and manage resolution program for product quality issues.
  • Implements J&J APAC BQ projects, such as Operational Excellence, LCM, and other commercialization activities, etc.
  • Supports regulatory Inspections and inspection readiness.
  • Monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.


Qualifications

Education and Qualification:

  • Doctorate/Masters +1, Bachelors +3 years of directly related experience in quality assurance and quality related activities.
  • Pharmacist license or Food quality experience is mandatory.
  • Regulatory inspection experience is desirable.
  • Experience in Japan with multiple language capability (English, Japanese)
  • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff.
  • Ability for travel to international destinations as needed.

Other Preferred Competency and Skills:

  • Demonstrated ability to manage relationship development and maintenance.
  • Comprehensive knowledge of Japanese regulations applicable to Drug, Quasi-drug and Cosmetics.
  • Good communication capability to facilitate effective interaction and motivate the team members.
  • Self leadership and motivation with high personal integrity and application of Johnson & Johnson value.

Experience performing GMP audits.


Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Johnson & Johnson K.K. (8235)
Job Function
Quality
Requisition ID
2105899289W

[Quality/Consumer]Business Quality Specialist

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