QC副经理

Lead the development of QC Chemical Lab organization and QC SMP/working instructions/ Specifications. Etc. in Shanghai Plant following the corporate quality strategies and initiatives.

83 作为用户，带领团队起草理化实验室设备URS，参与设备确认/验证工作。

Act as the user to lead the team to prepare URS for lab instruments, participate in the Q activities of chemical lab instruments along with the project timeline following the corporate Q&V program.

83 审核/起草实验室验证文件，确保符合法规要求。

Review/generate lab qualification/validation lifecycle deliverables and make sure compliance with cGMP requirements from regulations.

83 协助经理按质量要求改进实验室操作流程。

Work with manager to assist teams to improve operation process and activities related to Quality.

83 支持项目需要，完成测试方法转移，验证工作。

Support expansion project needs, which include Test Method Transfer and validation activities.

83 参与/指导理化实验室完成中间体产品，成品的相关检测工作。

Participate/Guide Chemical lab staff to complete related inspection of semi-finished products and finished products according to relevant product specification and SOP.02

83 负责复核日常测试记录，测试结果及报告使之合规，准确。

Responsible for reviewing original test records, data and reports, to ensure the authenticity, accuracy and integrity of data.

83 负责OOS 及偏差的调查。

Responsible for OOS handling & investigation.

83 仪器维护。

Instrument maintenance02

83 完成上级指派的其他职责。

Other duties as assigned by line manager.

技能要求Required Skills

83 大学本科或以上学历，药学/化工/化学分析等相关专业。

Bachelor degree or above, major in Pharmacy/Chemical/Chemical analysis or related subjects.

83 熟悉GMP实验室的法规相关要求。

Familiar with the regulator requirements of GMP Lab.02

83 熟悉Ch.P，EP和USP关于理化检测及仪器管理的要求。

Knowledge of the Ch.P, EP and USP with Chemical Testing and Instrument Management.

83 至少5年药品生产企业工作经验。

Minimum 5 years of working experience in pharmaceutical manufacturing.02

83 至少2年质量部管理岗位经验。

At least 2 years in management position in quality management.

83 具备一定的承压能力及独立解决问题的能力。

Ability to work under pressure and solve problems independently.

83 良好的英语能力，良好的计算机技能。团队合作，强烈的质量意识。

Good command of English, Good Computer skill. Hardworking. Teamwork. Strong quality mind set.