验证QA(J23420)

关键职责：

Key accountabilities

1. 熟悉实验室常规仪器操作如HPLC，GC，UV等

Be familiar with routine instruments operation, such as HPLC,GC,UV and etc.

1. 审核仪器验证、校准相关文件（SIA，URS， DQ/IQ/OQ/PQ方案，记录和报告）

Reviewing validation related documentation (SIA, URS, DQ/IQ/OQ/PQ protocols, records and report).

1. 审核偏差，CAPA，确认纠正及预防措施符合CGMP，SOP，QSG的要求

Reviewing deviations, CAPAs, making sure the corrective or preventative actions are in-line with cGMP, SOPs and QSG are correctly documented.

1. 审核变更，确保受影响的内容经过调查并且按照既定的规程记录

Reviewing change controls, making sure any change are documented according to defined procedure and all impacted items are investigated.

1. 作为验证的SME支持和复核审计相关的CAPAs

Support Audit as Validation SME and be responsible for the validation related CAPAs from Audit.

1. 主管分配的其他工作

• Other work and responsibilities assigned by the supervisor.
• 工作范围：

Scope of the job

1. 汇报给验证经理

Report to the QA Manager.

1. 与QA，QC及IT协同，确保cGMP及客户的需求得到满足

Work with QA,QC and IT to ensure that requirement of cGMP and customer are met.

1. 必须有GMP的工作经验

Must have experience in cGMP.

1. 熟悉验证相关法规，如NMPA, US FDA, EMA

Must be trained in or have experience with validation requirement of Chinese NMPA, US FDA, EMA GMP regulation.

1. 化学，制药相关本科及以上学历

BSc degree and above in a science discipline with experience or training in Chemistry, Pharmaceutical, or equivalent experience.

1. 良好书写及口头沟通技能

Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.

1. 良好的信息共享及团队工作能力

Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.