[innovative Medicine] Analyst, Quality Control Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)
Johnson & Johnson
Shizuoka, Japan
Onsite
Laboratory instrument lifecycle management
Data integrity requirements
Gmp/gctp compliance
Manage the full lifecycle of laboratory instruments and related software, including selection, qualification, calibration, troubleshooting, and decommissioning
Job Summary
Manage the full lifecycle of laboratory instruments and related software, including selection, qualification, calibration, troubleshooting, and decommissioning.
Drive alignment with HA/global data integrity requirements for laboratory instruments and associated software by assessing gaps, conducting risk assessments, and implementing risk mitigation measures.
Lead lab optimization projects to improve productivity and reduce cost, cycle time, inventory, and errors, achieving agreed financial targets.
Matching Summary
Manage the full lifecycle of laboratory instruments and related software, including selection, qualification, calibration, troubleshooting, and decommissioning.
Skills & Requirements
Must-have
laboratory instrument lifecycle management
data integrity requirements
GMP/GCTP compliance
risk assessment and mitigation
analytical testing experience
Nice-to-have
project management experience
collaboration and teamwork
proactive identification of risks
Key Requirements
Bachelor's degree in science or related field
Over 2 years of pharmaceutical industry experience
Experience in equipment qualification (IQ/OQ/PQ) is desirable