东莞招聘

1. 负责质量文件体系相关GMP文件的撰写工作。 检查、监督各车间GMP、SOP等相关文件的执行情况。

2. 负责工艺研发、GMP生产过程、QC、物料仓储、工程设备现场进行监控，确保生产全过程各关键质量控制点、卫生、状态标识、文件等符合相关程序和GMP要求。

3. 审核生产上、下游，采购仓储，工程设备等部门GMP相关文件。参与生产过程的偏差、不合格、变更、风险管理等分析，参与生产过程中的事故和质量事故调查的处理过程，参与产品质量相关的风险评估。

4. 审核原辅料、包装材料、中间产品、原液的质量标准，确保符合注册和客户要求。

5. 监督厂房和设备的维护，以保持其良好的运行状态。

6. 参与物料供应商审计，评估和批准物料供应商，建立合格供应商清单。

7. 审核批生产、批检验记录，确保产品放行前已完成所有的检验且结果合格。

8. 负责区域的内外审计的跟踪检查。

9. 参与GMP自检工作。

10. 完成上级主管交办的其他相关工作任务。

任职要求：

1. 本科及以上学历，药学、化学相关专业。

2. 3年以上QA经验或相关GMP申报经验，熟悉国内、国外药品的注册法规和GMP法规。

3. 英语四级以上，能够用英文进行读写和英语会话

4. 责任心强，具有较强的沟通能力。

Essential Functions of the job:

Take below responsibilities (Not all inclusive) to ensure cGMP compliance.

In-site Manufacture oversight

? Check and approve pre-manufacture release including room, equipment / instrument.

? Manufacture on-site oversight.

? Review and approve the blank and executed batch manufacturing / packing records.

? Review the Deviation / Change control / Incident occurred at manufacture process and make sure all documents above has been closed before product release.

? Prepare product release checklist and make sure each item in the checklist has been completed.

Out-site manufacture oversight

? Collect, review and approve the executed manufacture batch records and archive related batch documents.

? Review the Deviation / Change control / Incident occurred at manufacture process in contract company and make sure all documents above has been closed before product release.

? Prepare product release checklist and make sure each item in the checklist has been completed.

Warehouse oversight

? Distribution of material No.

? Prepare and distribute “GMP component inventory card” to warehouse operator and withdrawal.

? Oversight and verify recoding sheet of warehouse.

? Review the Deviation / Change control / Incident/ Risk Assessment/CAPA of warehouse related.

? Follow up the material destruction process and archive material destruction certificate.

Document management

? Preparation of GMP documents

? Ensure manufacture documents archiving properly as per SOP requirement.

? Review and approve the manufacture, facility and warehouse SOP act as a delegate of Quality head.

? Ensure warehouse related documents archiving properly.

? Review the Deviation / Change control / Incident/ Risk Assessment/CAPA occurred in the HVAC system and purified water system and compressed air system.

Others

? Prepare and participate in regulatory audit.

? Preparation of Annual Review Report of HVAC System and Cleanroom.

? To ensure that the appropriate validations are done for the workshop equipment / instruments / HVAC system / Purified water system / Compressed air system validation activities.

? Destroy the unused labels.

? Draft the overview and manufacture part of annual product review.

Complete the tasks assigned by QA manager.

Requirements include:

?Experience 3 years or above in quality assurance department, related education background in pharmacy or chemistry and expertise in pharmaceutical industry is a plus

?Fluent in English including speaking and writing

?Capability of controlling and completing multiple tasks with a clear sense of priority

?Ability to analyze and resolve issues

?Familiar with regulations, cGMP

深圳威立特尔生物科技有限公司（Shenzhen Veliter Biotechnology Co., Ltd ）是一家药用寡核苷酸（Oligonucleotides ）的CDMO 服务公司，专注于 Oligonucleotides 的工艺研发（Process Development）, scale up, non-GMP和GMP 制造。作为一家服务于寡核苷酸（Oligonucleotides ）应用领域的CDMO 公司，拥有团队合作理念是公司各项活动的基石。在威立特尔，个人专业领域特长和团队合作都得以公平尊重。欢迎加入我们。