2 jobs found in zhejiang

JOB SUMMARY:   This position is expected to be the Sr. MBR/PPQ Specialist of Drug Product department at Hangzhou site. Oversees and ensures the successful PPQ and MBR management in Drug Product department for the company.   Guarantee the production process of the injectable sterile pharmaceuticals is executed with the necessary robustness and the appropriate sterility assurance. Effectively arrange the Process Engineering activities including but NOT limited to: Process Performance Qualification, Master Batch Record management, Technique Transferring, Production handover etc. in conformity to the current SOP and the cGMP normative, safety & environment policy and labor law.   RESPONSIBILITIES: EHS Observe site EHS policy and rules and ensure the first goal of all employees is safety. Team and Employee Training Management -Provide related training course to the team: Ensure the constant and adequate level of training...

Key Responsibilities: Assist/engage in implementation of facility, equipment, and biotechnology process improvement projects. 实 施 设 施、 生物工艺 设备 和流程改 进项 目。 Engage in execution and writing of documents (specifications, protocols, and reports) related to facility, equipment, and process improvement of production process. 执 行和 编 写与生 产过 程的 设 施、 设备 和 过 程改 进 相关的文件（ 规 范、方案和 报 告）。 Engage in conduction of IQ, OQ, and PQ for new equipment. 执 行新 设备 的 IQ 、 OQ 和 PQ 。 Modification of SOPs and BPRs for new processes in accordance with change control policies. 根据变 更控制政策修改新工 艺 的程序和批 记录 。 Engage in in review BPR, SOP and logbooks for completion and insurance of accuracy of all documents as per GMP guidelines. 根据GMP  指南，参与 检查 批 记录 、 SOP 和 辅 助 记录 ，以确保所有文件的完成和准确性。 Participate / lead in deviation investigations. 参与/ 主 导 偏差 调查 。 Lead/participate implementation of corrective and...