[innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)
J&J FAMILY OF COMPANIES
Shizuoka, Japan
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Quality system compliance
Gmp/gctp activities
Data integrity management
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Johnson & Johnson is seeking a Quality Systems Specialist for their Innovative Medicine division at the Fuji Plant in Shizuoka, Japan. The role involves ensuring compliance with quality systems and regulations in the pharmaceutical industry, requiring over five years of relevant experience and a degree in a scientific field.
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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, and change control, and act as a point of contact with the Marketing Authorization Holder.
Support other group members' activities, troubleshoot issues, and lead or support new initiatives for business improvement.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Quality Systems Specialist for their Innovative Medicine division at the Fuji Plant in Shizuoka, Japan. The role involves ensuring compliance with quality systems and regulations in the pharmaceutical industry, requiring over five years of relevant experience and a degree in a scientific field.
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Skills & Requirements
Must-have
Quality system compliance
GMP/GCTP activities
Data Integrity management
Deviation management control
Change control management
Quality Agreements maintenance
Nice-to-have
Business-level English proficiency
Effective software application use
Leadership and coaching skills
Problem-solving and teamwork
Customer focus and continuous improvement
Key Requirements
Degree in Pharmacy, physics and chemistry or biology is preferable
More than 5 years of experience in pharmaceutical industry
Knowledgeable of GMP/GQP/QMS quality systems
Ability to effectively use software applications like MS Office, Trackwise