天津招聘

岗位职责:

1. 变更的管理Management of Change Control
1.1 负责变更文件的编号管理和登记。
Be responsible for numbering management and log of change control.
1.2 负责组织变更的风险评估、行动计划建立；并形成文件。
Be responsible for organize the risk assessment and action plan of change control and keep document.
1.3 负责变更行动计划的实施进展跟踪，确保变更按照预期的变更方案执行。
Be responsible for tracking the execution progress of action plans of change control, to ensure it is compliance with expected protocol.
1.4 负责定期收集典型案例，组织相关培训。
Be responsible for collecting typical cases and organizing relevant training.
1.5 负责变更的定期回顾。
Be responsible for periodic review of change controls.
1.6 负责变更文件的归档。
Be responsible for documents archiving of change controls.

2. 偏差的管理 Management of Deviation
2.1 负责偏差文件的编号管理。
Be responsible for numbering management of deviation.
2.2 负责组织偏差的根本原因调查、建立整改措施和预防措施；并形成文件。
Be responsible for organization of deviation rote cause investigation and CAPAs set up, and keep document.
2.3 负责定期收集典型案例，组织相关培训。
Be responsible for collecting typical cases and organizing relevant training.
2.4 负责偏差的定期回顾。
Be responsible for periodic review of deviations.
2.5 负责偏差文件的归档。
Be responsible for documents archiving of deviations.

3. 分析实验室的管理 Management of Analytical Laboratory
3.1 负责分析实验室管理文件、质量标准和检验方法的审核。
Be responsible for review of analytical laboratory management documents, specifications and test methods.
3.2 负责分析实验室检测数据的审核。
Be responsible for review of analytical laboratory test data.
3.3 负责分析方法确认/验证/转移方案、报告及数据的审核。
Be responsible for review of analytical method verification/validation/transfer protocol, report and data.
3.4 负责实验室相关稳定性考察方案、报告及数据的审核。
Be responsible for review of the stability protocol, report and data related to the laboratory.
3.5 负责审核实验室OOS调查、异常事件、偏差和变更控制。
Be responsible for review of laboratory OOS investigation, occurrence investigation, deviation and change control.
3.6 负责合同实验室的管理及审计。
Be responsible for contract laboratory management and audit.

4. 起草、审核、修订、复审职责相关的文件。
Prepare, review, revise, recheck the document related to the responsibility.

5. 起草审核本部门职责相关报告。
Prepare and review the report related to the responsibility.

6. 完成本部门领导安排的其他工作。
Complete the work assigned by supervisor.

任职资格:

1. 熟悉ICH Q7,GMP等相关法规。
Familiar with ICH Q7, GMP and relevant regulations.
2. 具有良好的语言基础（英文听说读写熟练）。
Have a good language foundation (Fluent in English both verbal and written.).
3. 具有很强的团队协作意识和沟通技巧。
Have strong sense of teamwork and communication skills.
4. 具有很强的任务执行能力。
Have strong ability of task execution.
5. 四年以上制药公司工作经验，两年及以上相关工作经验。
Four years and above experience of pharmaceutical company, two years and above relevant experience.
6.有计算机化系统验证经验优先考虑，如MES、SAP、DCS等。
Experience in computerized system validation is preferred, for example, MES, SAP, DCS, etc..

康龙化成新药技术股份有限公司成立于2004年，是国际领先的生命科学研发服务企业。经过多年发展，康龙化成打造了全方位的临床前药物研发及临床开发一体化平台，贯穿合成化学与药物化学、生物、药物代谢及药代动力学、药理、药物安全评价、放射标记代谢、工艺研发、GMP生产及制剂研发临床试验及临床样品的分析服务等各个领域，提供包括苗头化合物探索与靶标验证、先导化合物优化、临床前候选药物筛选、临床候选物的确认及临床开发、新药临床研究申请和新药申报等一体化研发服务。康龙化成在中国、美国、英国均有运营实体，全球员工人数15000+，业务遍及全球，服务客户包括世界前20大医药公司在内，已超过1500家。