Process design, set up methods of analysis and execute method transfer studies and ensure process compliance
SME on sampling or testing.
Head and document laboratory investigation as LI supervisor role
Perform problem solving related to testing of device, products, API, excipients and water for pharmaceutical use on reruns, deviations etc. in test operation teams. and support cross Dept.
Has ability to write methods of analysis and other operational documents and translate documents from English into Chinese.
Prepare for the audit and inspection and to be a auditee to answer the questions and be the finding owner to investigate and close the finding.
LIMS superuser or template builder
Implement QC 4.0 projects in local sites.
Perform PC and continuous improvement on QC process
Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write methods of analysis and other operational documents, translate key operational documents from English into Chinese.
Be familiar with general requirements in Pharmacopeia; Prepare analytical procedure according to Pharmacopeia; Identify the gap of local procedure and Pharmacopeia; Deep understanding of guidelines of Pharmacopeia.
Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations
Qualifications
4-yr (BS) D Degree in Microbiology, biology, Chemistry, Pharmacy, Engineering, Physical sciences or related field
Fluent in written and spoken English
Minimum 4 years of pharmaceutical QC Lab experience.
Previous experience with analysis and validation of medical device, water, excipients and API for pharmaceutical use desirable
Preference to have LIMS experience for template building and GMP/ ISO9001/ ISO13485 regulated industry
