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

Johnson & Johnson Johnson & Johnson · Pharma · Shizuoka, Japan

Staff position in Quality Operations at Johnson & Johnson's Fuji Plant, focusing on quality systems and regulatory compliance within GMP/GCTP environments. Responsibilities include overseeing regulated substances, managing approvals, handling change notifications, operating recall processes, and executing new initiatives. Requires a degree in Pharmacy/Chemistry or equivalent experience, with a strong background in pharmaceutical quality and GMP.

What you'd actually do

  1. Serve as the responsible person for regulated substances, overseeing operations conducted at the manufacturing site, maintaining records, preparing legally required documentation and submitting them to authorities, organizing regular meetings, managing assigned business activities, and handling inspections/investigations.
  2. Act as the process owner for ensuring alignment with regulatory approvals, managing the process, preparing documentation, and conducting assessments.
  3. Prepare and submit notifications of changes related to licenses and business categories held by the manufacturing site.
  4. Operate and manage recall processes as the GMP responsible person, ensuring compliance with applicable requirements.
  5. Execute new initiatives under the supervision and support of the supervisor.

Skills

Required

  • University degree in Pharmacy or Chemistry, or high school graduation with specialization in Chemistry and 4+ years of experience in manufacturing or handling psychotropic substances, or 7+ years of experience in manufacturing or handling psychotropic substances
  • Knowledge and experience in manufacturing or quality operations in a pharmaceutical facility
  • Knowledge and experience in GMP, GQP, and QMS quality systems
  • Ability to effectively use software applications (e.g., Microsoft Office)

Nice to have

  • Minimum 4 years of experience in the GMP field within the pharmaceutical industry
  • Business-level English proficiency
  • Analytical Reasoning
  • Business Behavior
  • Compliance Management
  • Controls Compliance
  • Cross-Functional Collaboration
  • Execution Focus
  • ISO 9001
  • Issue Escalation
  • Performance Monitoring
  • Persistence and Tenacity
  • Quality Auditing
  • Quality Control (QC)
  • Quality Standards
  • Quality Systems Documentation
  • Report Writing
  • Technologically Savvy
  • Vendor Selection

What the JD emphasized

  • GMP/GCTP
  • GMP
  • GMP field
  • quality systems
  • QMS quality systems
  • regulated substances
  • regulatory approvals
  • GMP responsible person