The role involves ensuring GMP-compliant operation of the physicochemical laboratory area while managing process water monitoring and testing protocols
Job Summary
The role involves ensuring GMP-compliant operation of the physicochemical laboratory area while managing process water monitoring and testing protocols.
Candidates will be responsible for drafting quality standards, SOPs, and validation reports for materials, intermediates, and finished products including plasmids and CAR-T therapies.
The position requires strict adherence to data integrity policies (ALCOA+) and active participation in investigating quality events such as deviations and out-of-specification results.
Matching Summary
The role involves ensuring GMP-compliant operation of the physicochemical laboratory area while managing process water monitoring and testing protocols.
Skills & Requirements
Must-have
GMP regulatory compliance experience
Physicochemical testing of raw materials
SOP and protocol drafting skills
Process water monitoring expertise
Data integrity ALCOA+ adherence
Deviation and OOS investigation
Nice-to-have
Strong English communication skills
Experience with viral vector testing
Supplier audit support capability
Trend analysis reporting ability
Key Requirements
Associate degree or above in Chemistry or Biology
Three or more years of pharmaceutical testing experience
Familiarity with national pharmacopoeias and GMP regulations