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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at MSオフィス

行動特性

• チームワーク
• コミュニケーション力
• 問題解決能力
• 学ぶ姿勢
• 正確な作業

Position Summary:

This Job Description applies to the position of Quality System Group at JPKK Fuji Plant.

Perform tasks related to quality systems in GMP/GCTP and tasks related to Controlled substances compliance.

• 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.
• Act as the process owner for ensuring alignment with regulatory approvals managing the process preparing documentation and conducting assessments.
• Prepare and submit notifications of changes related to licenses and business categories held by the manufacturing site.
• Operate and manage recall processes as the GMP responsible person ensuring compliance with applicable requirements.
• Execute new initiatives under the supervision and support of the supervisor.

Candidates must meet at least one of the following criteria:

• A degree in Pharmacy or Chemistry from a university
• Graduation from high school with a specialization in Chemistry and minimum 4 years of experience in manufacturing or handling psychotropic substances
• Minimum 7 years of experience in manufacturing or handling psychotropic substances
• Preferably minimum 4 years of experience in the GMP field within the pharmaceutical industry

• Knowledge and experience in manufacturing or quality operations in a pharmaceutical facility
• Knowledge and experience in GMP GQP and QMS quality systems
• Business-level English proficiency (preferred)
• Ability to effectively use software applications (e.g. Microsoft Office)

• Teamwork
• Communication skills
• Problem-solving ability
• Willingness to learn
• Accuracy in work execution

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