QC&A Chemist

Main Responsibilities:

•  Develop and review method transfer protocol, analytical methods verification and validation, equipment qualification, laboratory procedures, evaluation and implementation of new technologies.
• Coordinate with Corporate and CGAM sites laboratory process improvements.
• Perform routine and non-routine activities according to established SOPs with minimum supervision according to established SOPs.
• Responsible for the arrangement, coordination and/or support of projects involving R&D, QC, Corporate and external customer as requested; ability to lead, write, execute and coordinate laboratories qualification/validation activities and test method validation.
• Responsible for the oversight of laboratory computerized systems.
• Identify continuous improvement initiatives, including workflow processes to improve productivity.
• Perform duties as assigned by supervisor according to compliance and business needs.

Main Requirements:

• Minimum 3 to 5 year relevant experience in the pharmaceutical / API industry.
• Good knowledge of analytical / incoming testing (GC, HPLC, KF, NMR preferred); demonstrated experience in method verification / validation, laboratory investigation, equipment qualification and trouble-shooting.
• Knowledge of cGMP concept (i.e. ICH guidelines, FDA, EMA, NMPA).
• Fast learner with ability to adapt to changes, and with continuous improvement mindset; able to write and communicate well in English and in Chinese language.