Clinical Operations and Regulatory Affairs, Suzhou | 30 Sep 2021
Responsible for Chemical test in QC laboratory
Principle Roles & Responsibility
Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
Execute the finished product stability testing, and initial the relevant stability reports.
Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
Initial and revise the protocol of method transfer and validation for chemical testings;
Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
Report the OOS results, and conduct laboratory investigation per line manager instruction;
Provide specific information when communicating with government drug testing agencies;
Responsible for the safety, health and environmental protection (EHS) of itself position;
Complete other tasks assigned by line manager.
Qualification and Experience
College degree or above in pharmacy relevant major;
2 years of relevant work experience;
With good physical and chemical testing skills and knowledge;
Familiar with chemical laboratory procedures， laboratory instrument operation and regulatory requirements;
Experience with chemical method validation is preferred;