Johnson & Johnson Careers

Sr. QA Manager

Shanghai, China
Quality Assurance


Job Description

Requisition ID: 1700208936W

主要工作职责Responsibilities& Duties

·        严格监控和质量相关的各个活动,包括采购、生产、检测、贮存、货运等各个环节,并协助各部门做好生产现场管理工作,使得产品生产的全过程都在严密的监控下进行。

Manage GMP which covers all matters, which individually or collectively influence the quality of product.

·        负责生产/质量管理有关程序的起草、审核和批准。

Responsible for initial, review and approval of applied procedure of production/quality.

·        负责批生产记录和批检验记录的审核,经授权后释放产品。

Responsible for review of batch record and testing report; responsible for finished product release when authorized.

·        参与各类验证文件的审阅及验证活动的监督。

Review validation documents and conduct supervision when necessary.

·        负责变更控制和变更的审核。

Responsible for Change control review.

·        负责偏差的管理和调查,在适当的时候签发预防纠正措施,并负责进行追踪和评估。

Responsible for non-conformance investigation and management, approve, tracking and evaluate CAPA when necessary.

·        负责质量相关客户投诉的调查及监督纠正与预防措施的执行。

Responsible for quality related customer complaint investigation and implantation of CAPA when necessary.

·        负责管理并协调本部门员工项目安排,制定并实施培训计划。

Responsible people development including training of responsible department.

·        负责产品的年度质量回顾。

Responsible for product annual review.

·        负责不合格品的批准和监督处理的执行(如返工、销毁)。

Responsible for reject material and finished products approval, as well as the destruction process.

·        负责返回产品的处置批准。

Responsible for returned products disposition approval.

·        参与内部和外部的审计。

Participate in internal and external audits.

·        遵守环境、安全和健康准则。

Comply with EHS requirements.

·        遵守公司的规章制度和HCC的规定。

Comply with company rules and regulations and HCC policy

·        有义务按公司投诉程序将客户投诉电话转至相关部门。

Be obliged to transfer the customer complaints to relevant department under customer compliant procedure; and involve in the handling of customer complaints if necessary;

·        上级主管交付的其它相关工作

Other work assigned by supervisor

 


Qualifications

本科或本科以上, 药学、化学或其他相关专业。

Bachelor Degree or above, with pharmaceutical, chemistry or other related major.

五年以上工作经验,熟悉GMP体系,具有在制药行业的质量管理经验,了解如何制定质量标准和标准操作程序,有组织和管理能力,对原材料和生产过程控制比较熟悉。

-    5 years above working experience in related industry including the quality management experience in pharmaceutical industry.

-    Familiar with GMP system

-    Strong leadership

-    Familiar with SOP initiation, review and approval process

Familiar with raw materials and manufacturing control process.

·          良好人际交往和沟通能力

Excellent communication skills

·          良好的组织和领导才能

Strong people management and leadership skills

·          良好的发现问题和解决问题的能力

Good at problem detecting and solving ability.

·          良好的团队合作意识

Good team player.

·          良好的英语表达能力

Good at in both written and oral English.

·          计算机操作能力强

Good computer skills.

·          职能相关能力请参照胜任力模型

The relevant ability by functions refer to competency model

·          领导能力请参照全球领导力特征

Language proficiency in English and Putonghua is essential

Primary Location
China-Shanghai-Shanghai
Organization
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)
Job Function
Quality Assurance
Requisition ID
1700208936W