[innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)

Johnson & Johnson UK

Shizuoka, Japan
On-site
Gmp/gctp regulations
Quality system compliance
Data integrity management
Johnson & Johnson is seeking a Quality System Specialist for their Manufacturing and Supply Division in Shizuoka, Japan. The role involves ensuring compliance with quality systems in the pharmaceutical industry and requires over five years of relevant experience

Job Summary

  • Perform assigned quality system and compliance-related activities in accordance with regulations and corporate policies.
  • Manage GMP/GCTP activities including Data Integrity, Deviation management, and Change control.
  • Act as the point of contact with the Marketing Authorization Holder for quality agreements and reporting requirements.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Quality System Specialist for their Manufacturing and Supply Division in Shizuoka, Japan. The role involves ensuring compliance with quality systems in the pharmaceutical industry and requires over five years of relevant experience.

Skills & Requirements

Must-have

  • GMP/GCTP regulations
  • quality system compliance
  • data integrity management
  • deviation management
  • change control management

Nice-to-have

  • business-level English proficiency
  • leadership skills
  • problem-solving skills
  • teamwork and collaboration

Key Requirements

  • 5+ years of experience in pharmaceutical quality
  • Degree in Pharmacy, physics and chemistry or biology
  • Knowledgeable of GMP/GQP/QMS quality systems
  • Proficiency with MS Office and Trackwise software

Work Rights

Not specified

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