• Clinical and Commercial Process validation project management for QC part.
• Manage method transfer/validation/verification activities
• Solutions preparation and reference standardization
• Instrument calibration/ qualification /maintenance
• Manage analytical method/specification preparation and MBR review
• Optimize the method during the method transfer or validation
• Client Communication during the project management
• Prepare and review related GMP document, perform timeline and resource management to ensure the projects meet the expected quality and within the desired timelines and budget.
• Provide technical guidance/direction to the team to enhance department capabilities.
• IP and safety operation

• Education: Chemical, Biochemical, Pharmaceutical or related background and master or above
• Experience: above 2 year relevant experience or excellent graduate
• Basic skills of HPLC/GC, and etc.
• Basic knowledge of cGMP
• Be familiar with requirements of FDA, EMA and NMPA regulations, ICH guidelines
• Good communication and coordination skills
• Good analysis and problem resolve skills
• Good communication skills in written and verbal English, outstanding interpersonal skills are essential job requirements.

LOCATION

Jinshan, Shanghai City

CONTACT

Please send your resume to: elsa_li@wuxiapptec.com / wu_danjing@wuxiapptec.com