- 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;
- Experience with USP and EP is preferred.
If interested, please forward your resume to firstname.lastname@example.org