锦鲤求职岗位描述
岗位职责 Responsibilities
项目管理与客户对接
负责制剂项目的全生命周期管理，包括项目引入、工艺转移、生产协调及项目交付；作为项目主要接口，负责客户沟通、需求澄清及项目进度跟踪，确保项目按计划推进并顺利交付。
Project Management & Client Communication
Manage the full lifecycle of drug product projects, including project onboarding, technology transfer, manufacturing coordination, and project delivery. Serve as the primary client contact, ensuring effective communication, requirement alignment, schedule tracking, and successful project execution.
跨部门协调与执行推动
统筹客户、生产、质量保证（QA）、质量控制（QC）及研发等相关部门资源，协调解决项目实施过程中的问题与风险，推动项目高效落地。
Cross-functional Coordination & Execution
Coordinate resources across clients, Manufacturing, Quality Assurance (QA), Quality Control (QC), and R&D functions to facilitate project execution, proactively address risks and challenges, and ensure timely project delivery.
文件管理与技术支持
负责项目相关文件的编制、审核和维护，包括批生产记录（BPR）、工艺文件、验证方案及项目报告等，确保文件符合GMP要求及客户需求。
Documentation Management & Technical Support
Prepare, review, and maintain project-related documentation, including Batch Production Records (BPRs), manufacturing documents, validation protocols, and project reports, ensuring compliance with GMP requirements and customer expectations.
质量与合规管理
跟踪并协调项目过程中的偏差（Deviation）、变更（Change Control）、CAPA及OOS调查处理，推动问题及时关闭，确保项目全过程符合法规和质量管理要求。
Quality & Compliance Management
Track and coordinate deviations, change controls, CAPAs, and OOS investigations throughout project execution, ensuring timely resolution and compliance with regulatory and quality requirements.
风险管理与持续改进
负责项目风险识别、评估与控制，推动风险缓解措施有效实施；结合项目实践经验，持续优化项目管理流程和生产运营效率。
Risk Management & Continuous Improvement
Identify, assess, and mitigate project risks, implement effective risk control measures, and continuously improve project management processes and operational efficiency based on project experience and best practices.
新业务与平台建设
参与新产线建设、设备验证、工艺导入及持续优化工作，为新项目引进和生产能力提升提供技术与项目管理支持。
Business Expansion & Platform Development
Support new production line start-up, equipment qualification, process implementation, and continuous improvement activities, providing technical and project management expertise for business growth and manufacturing capability enhancement.
任职要求 Qualifications
教育背景
制药、生物工程、药学、生物学等相关专业硕士及以上学历。
Education
Master's degree or above in Pharmaceutical Sciences, Biological Engineering, Pharmacy, Biology, or other related disciplines.
专业经验
具备生物制药或制剂生产相关工作经验，有项目管理或工艺转移经验者优先。
Professional Experience
Relevant experience in biopharmaceutical or drug product manufacturing; project management or technology transfer experience is preferred.
法规与质量意识
熟悉GMP法规及药品生产管理要求，具备良好的质量与合规意识。
Regulatory & Quality Knowledge
Good understanding of GMP regulations and pharmaceutical manufacturing requirements, with a strong quality and compliance mindset.
项目管理能力
具备优秀的项目管理能力及跨部门沟通协调能力，能够有效推动项目执行。
Project Management Skills
Strong project management and cross-functional communication skills, with the ability to drive project execution effectively.
英语能力
英语可作为工作语言，能够独立开展英文会议沟通及技术文件编写。
English Proficiency
Proficient in English as a working language, capable of conducting meetings and preparing technical documentation independently.
综合能力
具备较强的问题分析与解决能力、执行力及客户导向意识，责任心强，并能够适应多项目并行管理环境。
Core Competencies
Strong analytical and problem-solving skills, execution capability, customer focus, and a high sense of accountability, with the ability to thrive in a dynamic multi-project environment.