The role involves establishing GMP-compliant laboratory procedures and ensuring the normal operation of the physicochemical testing area
Job Summary
The role involves establishing GMP-compliant laboratory procedures and ensuring the normal operation of the physicochemical testing area.
Candidates will be responsible for drafting quality standards, SOPs, and protocols for validation and stability studies related to materials and finished products.
The position requires maintaining data integrity by strictly adhering to ALCOA+ requirements and investigating any quality events or deviations.
Matching Summary
The role involves establishing GMP-compliant laboratory procedures and ensuring the normal operation of the physicochemical testing area.
Skills & Requirements
Must-have
GMP regulatory compliance expertise
Physicochemical testing of raw materials
Analytical method validation protocols
Process water monitoring and analysis
Deviation and OOS investigation skills
Data integrity ALCOA+ standards
Nice-to-have
Experience with CAR-T and lentiviral vectors
Strong English communication abilities
Supplier audit support experience
Trend analysis reporting capabilities
Key Requirements
Associate degree in Chemistry or Biology
Three or more years pharmaceutical testing experience
Familiarity with national pharmacopoeias and GMP regulations