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

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

Staff position in Quality Control Group at Johnson & Johnson's Innovative Medicine division in Japan. The role focuses on implementing, improving, and harmonizing laboratory quality systems in compliance with GMP/GCTP and J&J guidelines. Responsibilities include leading the transfer of analytical methods, overseeing QC activities for new product launches, ensuring system compliance for regulatory filings, managing stability programs, and supporting projects to improve efficiency and reduce costs. Requires a Bachelor's degree in a science field, 3+ years of pharmaceutical industry experience, and experience in GMP-compliant lab systems.

What you'd actually do

  1. Responsible for implementation, improvement and harmonization of laboratory quality systems.
  2. Lead with transfer of analytical methods between other sites and Fuji and Lead QC activities for the new product launch.
  3. Responsible for ensuring all laboratory systems comply with GMP/GCTP and J&J guidelines and quality standards, including support to regulatory filings and sub-system owner for laboratory systems.
  4. Perform the activities, encompassing activities in support of laboratory systems, e.g. , stability program administration, analytical change control, Empower, training, etc.
  5. Ensures required GMP/GCTP, EHS and role-related training required to work safely and in compliance with regulatory requirements and as defined by their training matrix.

Skills

Required

  • GMP/GCTP and Data integrity
  • Pharmaceutical regulations, standards, and guidelines
  • Experience in analytical testing, instrument analysis, and equipment management
  • Proficiency in documentation (e.g. SOP, WI, lab worksheet, and assessment)
  • Ability to use basic PC software, including Microsoft Office and analytical software such as Empower (usage of software applications for data entry, data analysis, word processing, presentations, and calculations)
  • Good communication skills in English (both written and verbal)
  • Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields.
  • Over 3 years of work experience in the pharmaceutical industry
  • Experience in laboratory or laboratory systems-related activities under GMP-compliant conditions

What the JD emphasized

  • GMP/GCTP
  • Quality Systems
  • Regulatory Compliance