Analytical Scientist
35~40K 人民币/每月
全职
3~5年
刷新于 2 年前
63 查看
2 申请
广州
分享
工作职责
Support the start-up of Quality Systems for the site.
Execute and maintain the Quality Systems at the site.
Document Management System
Write, Revise, Review and Approve Standard Operation Procedure, protocols, reports or records.
Conduct training
Provide guidance on Current Good Manufacture Practices, Good Documentation Practices and Data Integrity requirements.
Training/Learning Management System
Maintenance of training curriculum/tasks.
Custodian and archival of training records.
Provide guidance on Learning Management System usage.
Trackwise System
Provide guidance on deviation management, change control and Corrective And Preventive Actions
Conduct training and provide guidance on trackwise system usage.
Communicate quality systems and compliance requirements effectively to peers and stakeholders.
Provide compliance support to staff in all departments.
Participate in regulatory, customer and internal audits.
Any other tasks as and when assigned by the supervisor/line manager.
职位要求
Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
Good knowledge and experience of the practical and theoretical requirement of validation program in Good Manufacture Practices facility
Good leadership skills
Strong interpersonal skills
Effective Communicator (oral and written)
Exhibit good quality decision making traits
Meticulous and Systematic
Analytical Mind
Ability to define specific goals clearly, to develop and prioritize activities
Team player, with strong focus on safety, quality and timelines
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