[innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)
Johnson & Johnson
Shizuoka, Japan
Onsite
Gmp/gctp compliance
Data integrity
Deviation management
Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group staff
Job Summary
Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group staff.
Manage GMP/GCTP activities such as Data Integrity, Deviation management control, Change control.
Acting as the point of contact with the Marketing Authorization Holder, including maintaining Quality Agreements, implementing reporting requirements for deviations and related events and audit management.
Matching Summary
Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group staff.
Skills & Requirements
Must-have
GMP/GCTP compliance
Data Integrity
Deviation management
Change control
Quality Agreements
Nice-to-have
Trouble shooting
Process improvement
New initiative support
Key Requirements
5+ years experience in pharmaceutical quality
Degree in Pharmacy, physics and chemistry or biology