Regional Compliance Auditor
硕腾(上海)企业管理有限公司 Zoetis Enterprise Management (Shanghai) Co., Ltd.
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-04-29
- 工作地点:上海-长宁区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位类别:药品生产/质量管理
职位描述
POSITION SUMMARY
The Regional Compliance Auditor will conduct on-site audits of Zoetis manufacturing sites, contractors and suppliers – with the goal of determining compliance gaps and necessary remediation plans. The auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.
The RCA will (as needed) assist with mock regulatory inspections as well as supporting agency inspections. Additonally – the auditor will gather, track, trend, and disseminate regulatory compliance findings – from internal as well as external inspection sources.
The RCA will work closely with QSS and Surveillance colleagues to stay abreast of current compliance regulations and points of key inspection trends.
POSITION RESPONSIBILITIES
Conducting quality audits of global and regional Zoetis Global Manufacturing and Supply Sites (GMS), Suppliers and Contractors
- Conduct Mock PAI and inspection readiness assessments at GMS Sites and contractors
- Support due diligence assessments
- Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
- Follow up and tracking of CAPA completion
- Train sites and center colleagues on conducting audits (auditor qualification)
- Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis quality assurance programs.
- Zoetis Quality Culture ambassidor
ORGANIZATIONAL RELATIONSHIPS
- Manufacturing Operations
- Manufacturing GMT
- QSS, QPL
- VMRA VMRD
- GSS
- ESQA, SCQO
- Manufacturing IT
RESOURCES MANAGED
Supervision
Highly matrixed organization; Influence without authority necessary
EDUCATION AND EXPERIENCE
- Science or Engineering Bachelors / Masters Degree
- Significant Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing
- Previous Animal Health/Human Health audit experience
- Demonstrated ability to operate successfully in a matrix organization
- Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
- Experience in working with FDA, EU, USDA, Chinese regulations.
TECHNICAL SKILLS REQUIREMENTS
- Demonstrated knowledge in Quality Operations
- Fluent with compliance regulators
- Excellent communication skills (written, oral, and listening)
- Demonstrated independent contributor and ability to manage independently
- Deep expertise in planning, organizing, and follow up methodology; punctual
- Ability to develop and adhere to self-directed standard work.
- Ability to analyze data and synthesize to enable tracking and trending of large issues
- Process Owner Management
- Continuous Improvement; Systems and Process mindset
PHYSICAL POSITION REQUIREMENTS
- Location: APAC region (Singapore preferred, or Shanghai)
- Position requires flexible work hours, to accommodate varying sites, locations, and markets’ time zones
- This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites
- Travel: Estimated 50% global travel
ACRONYM DEFINITIONS
- QSS: Quality Systems and Standards
- QPL: Quality Platform Leader
- QA: Quality Assurance
- QC: Quality Control
- ESQA: External Supply Quality Assurance
- SC QO: Supply Chain Quality Operations
- GMS: Global Manufacturing and Supply
- VMRA: Vetrinary Medicine Regulatory Affairs
职能类别: 药品生产/质量管理
公司介绍
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals.
Why Zoetis
Zoetis has more than 60 years of experience in delivering innovative, high-quality products and services that benefit our customers.
Zoetis work environment
At Zoetis, we take pride in a collaborative spirit and high-performing environment where every colleague is given room to learn and grow.
Your opportunities at Zoetis
We invest in our people and offer diverse and exciting opportunities to make a difference in a growing global industry while shaping the future of animal health.
Results that matter
Our colleagues make an impact by working hand-in-hand with those who raise and care for animals to better understand and address the unique real-world challenges they face.
硕腾,原为辉瑞的动物保健部门,作为一家全球领先的动物保健公司,致力于为客户及其业务提供最有力的支持。秉承60年的悠久历史,我们为用户提供优质的兽药和疫苗、业务支持和技术培训。
在《福布斯》“2017年美国***雇主(中型企业)”中硕腾公司也有幸入选,这是硕腾公司第二年入选,排名在Top300中列114位。这份殊荣是对硕腾的工作环境、公司文化和企业品牌的认可。我们将继续不懈努力,帮助饲养和关爱动物的人们,为他们解决所面临的各种挑战。
我们的英文名字Zoetis (zō-EH-tis),其词根为zo,以 zoo(动物园)和zoology(动物学)而广为人知。Zoetis源于zoetic(有生命的,有生气的),蕴含“赋予生命的意义”之义。硕腾(Zoetis)致力于为世界各地的饲养和关爱动物的兽医和畜牧从业人员提供支持。
联系方式
- Email:tianlong.wu@zoetis.com
- 公司地址:上海市虹口区四川北路88号星荟中心2座21-22楼