DP 4-制剂生产项目管理

1. 01

   参与工艺技术转移，设施/工艺适配，新产品引入评估，负责BOM和PFD，MBR等文件的撰写和签批； Participated in process Tech Transfer, Facility/Process Fit, evaluation of new product introduction, responsible for writing and signing BOM, PFD, MBR and other documents;

2. 02

   参与场地变更/设备变更/物料变更/工艺变更的技术评估和影响分析； Participate in technical assessments and impact analysis of site changes/equipment changes/material changes/process changes;

3. 03

   参与工厂内新型上游技术/设备引入的技术评估与影响分析，并参与验证； Participate in the technical assessment and impact analysis introduced by new upstream technologies/equipment in the facility, and participate in the validation;

4. 04

   负责客户投诉调查，生产偏差的调查和偏差报告撰写，审核和签批； Responsible for client complaint and manufacturing deviation investigation and deviation report writing, reviewing and signing;

5. 05

   负责审计协调，厂房介绍及审计相关问题答复，确保审计顺利开展以及整改跟进。 Responsible for audit coordination, facility introduction and audit related issues response to ensure smooth audit and rectification follow-up.

Education 食品科学，药学、微生物学、生物或化学工程或相关专业硕士学历 Master or above in pharmaceutical, Food Science, Microbiology, Biological/Chemical engineering, or related major. Experience 具有审计质量文件撰写和项目管理经验者优先 Candidates with experience in audit quality document drafting and project management are preferred. Skills 1具有良好的英语读写能力，英语可作为工作语言。 Good in reading and writing of English. To use English as working language.

2. 02

   熟悉使用计算机。Good skills in using computer.

3. 03

   项目管理。Project management.

4. 04

   有较强的分析问题能力及良好沟通技巧，工作认真、细致，具有良好的团队合作精神。Excellent ability in analysis, communication skills and problem-solving. Work hard and carefully with strong team cooperation ability

5. 05

   综合工时制Comprehensive Working Hours System.