Responsibilities & Duties 职责
Quality Management System in Changshu Plant
1. Maintain quality system to comply with ISO9001, ISO15378 requirement including internal/external audit.
2. To ensure the plants system complying with Chinese pharmaceutical regulations.
3. Organize monthly quality meeting on quality topics.
Quality Assurance
1. Non-conformance and customer complaint handling, organize meeting with relevant parties for RCA and CA.
2. QNS (Customer Complaint in SAP) maintenance and CAPA folow up. Keep responding time within the target.
3. Conduct supplier/sub-contractor management including supplier audit and qualification.
Quality Control
1. Initiate quality procedure and working instruction regarding to ISO9001, ISO15378 and cGMP requirement.
2. Manage quality control of raw material and finish goods including in process control and final releasing.
3. Plan, establish and maintain calibration and preventive maintenance program of assigned equipment and instruments to obtain the accuracy and reliability of testing equipment and basic trouble shooting in case of problem.
Performance of people
1. Set target and keep monitoring the performance for QC team.
2. Coaching, training and advising lab technicians and IPC
Interaction with other functions ( Marketing, Sales, D&A)
1. Manage customer requirement on technical know-how.
2. Support D&A and production team for validation of new products/machine/process.

Key Requirements 招聘要求
1. College degree or above in microbiology, pharmaceutical, chemical or other related specialty.
2. 5 years or more of work experience in quality control area (both microbe and normal lab). Familiar with GMP requirement and microbe test of food and drug.
3. Team leader; communication skills; leadership ability. Excellent analyzing ability and structured working style. Able to work in competitive environment under pressure
4. Working in an international company and knowing pharmaceutical package manufacturing process is preferable.
5. Good English skills in both writing and reading. Fluent speaking English skill is preferred.