QA specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Xian, Shaanxi, China

Job Description:

• 现场管理：对GMP 执行情况进行日常监督检查，及时填写检查记录；对发现的问题及时提出纠正及预防措施，并监督检查实施结果；

• 文件审核：

o 对生产批记录和包装批记录进行审核，进行SAP 系统维护并及时传递；

o 对新产品试验批记录、返工批记录、返工单、特征批和验证批批记录进行审核；

o 在规定的时限内，对空白批记录进行审核和批准；

o 审核批准主数据；

• 体系管理：对不符合事件进行现场管理和调查，确定根源并制定纠正预防措施，跟踪实施结果；对变更进行生产现场的影响评估，跟踪实施活动的执行情况；按照GMP 要求管理、监控剔除品和返回产品；跟踪关闭CAPA ; 处理客户投诉；对人员进行培训和IPC 资格认证；

• 文件起草：按时完成分配的产品年度回顾报告，PPQS 及文件周期性回顾工作；

• 沟通与协作：与上级和同事之间及时沟通信息；与工作相关部门之间进行良好的沟通与反馈；进行团队合作和跨部门协作；

• 了解所有与职位相关的安全、环境、工业卫生规范，在生产中严格遵照执行；

• 负责不合格品销毁，特殊药品需与药监部门沟通。

o 特殊药品管理：

• 确保日常操作符合特殊药品安全管理制度及相关文件要求。

• 组织制订安全管理文件，并指导、监督文件的执行。

• 负责指导并监督特殊药品生产全过程的安全管理工作。

• 组织开展安全管理教育和培训。

• 负责管理监控系统和报警装置，定期组织检查，保证正常运行。

• 负责异常情况和安全事件的调查、处理及报告。

• 组织实施安全管理体系的自检，并对安全风险管理措施的有效性进行评估。

o 培训：对新进的现场QA 人员进行现场巡检，文件审核和文件起草培训。

教育和证书EDUCATION & CERTIFICATIONS：

1.专业知识Specific knowledge

▪ GMP 相关知识

▪ 现场管理经验

▪ 制药工艺和包装工艺

▪ 药用包装材料专业知识和管理经验

2. 个人（领导力）技能 Personal and interpersonal skills / Leadership skills

▪ 项目管理经验 Project Management Experience

▪ 诚实正直、紧迫感、求知欲、协作和团队精神、自我认知及适应能力

Integrity and honesty, sense of urgency, curiosity, collaboration and team spirit, self‑awareness and adaptability

▪ 熟练使用Windows 操作系统和常用办公软件

Proficient in the Windows operating system and common office software

▪ 能用中文流利的书写和交流

Fluent in written and spoken Local Language (ideal not a must) +

Must =精通英语的书写和交流 Must = Fluent in written and spoken English

3. 个人态度和心态Personal attitude and mindset

▪ 以创新和改变为驱动，保证竞争力Drives for innovation and change to ensure competitiveness

▪ 乐观进取的心态，能够在拔高的目标和时限要求下敏捷，灵活性工作

Can-do mentality, agility & flexibility able to work with stretched goals and deadlines

▪ 愿意将团队的目标放在第一位并与团队其他人一起朝着目标努力

Willing to place the goals of the team first and work with others towards these goals

▪ 能沟通，有动力，能谈判，有自信，对他人有影响力的人

Communicative / Motivator / Negotiator / assertive person having impact

▪ 对相关专业活动有高度责任感Showing a high sense of responsibility regarding professional activities

▪ 能应对市场、认证、供应商等的变化 Ability to deal with changes from market, compliance, suppliers and others.

4. 良好的生产规范Good Manufacturing Practices (GMP)

▪ 坚持遵守GMP 的程序Adhere to applicable cGMP’s and procedures (role model)

▪ 报告事故和偏差Report incidents and deviations

▪ 提出改善符合GMP 的解决方案Propose solution to improve compliance with cGMP’s

5. 安全，健康和环境绩效Safety, Health and Environment Performance

▪ 坚持遵守EHS 的程序Adhere to applicable EH&S and procedures (role model)

▪ 报告事故，偏差Reporting of (near) accidents, incidents, deviations

▪ 配合和建议方案提高EHS 程序Cooperate on and suggest solutions to improve EH&S

▪ 当看到违反EHS 规则的行为要及时制止，做出适当的行动

Act when violation of EH&S rules is observed and stimulate appropriate behavior

相关经验RELATED EXPERIENCE:

5 年以上医疗行业工作经验，3 年以上跨国公司工作经验

5 years working experience in pharmaceutical industry, 3 years working experience in MNC.

学位DEGREE:

制药学、化学、生物化学、制药工程专业本科以上学历

Bachelor degree or above in pharmaceutical, chemical, biochemical, pharmaceutical engineering

专业系统SPECIFIC SYSTEMS:

• 质量控制与管理技能

• 文件控制技能

• 培训技能

• 内部审计技能

 

 

Required Skills:

 

 

Preferred Skills: