BASIC FUNCTIONS:
Responsible for Chemical lab routine testing of raw material and finished product within required testing cycle time. Involve in lab validation, investigation, audit, and troubleshooting. Support internal and external project implementation.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1 Routine testing and reviewing work: Perform testing for raw materials, finished products, stability samples, bulk samples, and complaint samples within required testing cycle time. Review raw data in time and make sure that the record meets GMP and GLP compliance requirements. -- 50%%
2 Conduct preliminary investigation for Lab OOS/Non-conformance, complete the investigation under the guidance, and report to supervisor timely. Complete related actions defined in the Change Request with guidance. -- 10%%
3 Draft or update compliant SOP/WI according to the actual operation process and guide employees. -- 5%%
4 Complete validation works according to validation protocol independently -- 5%%
5 Technical support: Provide relevant technical support about chemical analysis during project implementation. -- 5%%
6 Responsible for the Lab equipment management, ensure all equipment calibration/maintenance complete timely. Responsible for new equipment purchase and validation, ensure new equipment is fully validated before use. -- 5%%
7 Regulation compliance: Comply with requirements of ISO13485, GMP, 21CFRPart 820, 21CFRPart 211 and company standards. -- 10%%
8 Follow up local regulations and JNJ policy of EHS strictly, wear appropriate PPE at work and report any potential EHS risk. -- 5%%
9 Others: Perform other tasks, such as the urgent task in the team. -- 5%%
EDUCATION AND EXPERIENCE:
1. Pharmacy, pharmaceutical analysis, analytical chemistry or related major, Junior college degree or above, with at least two year’s work experience in Chemical lab of pharmaceutical or international medical device company.
2. Common knowledge of GMP and GLP.
ESSENTIAL SKILLS AND ABILITIES:
1. Professional English reading & Listening.
2. Be able to use PPT to prepare reports and use Excel/other laboratory quality control software to perform data analysis and graph it.
3. Be able to communicate with other departments, understand and implement the related tasks.
4. Coordinate internal project.