长沙招聘

职位描述：
Key Responsibilities:
The main interface of the GMP topics from CBRE team to Roche perspectives including QA/Production/QC/Warehouse and etc.

Attendance of both facility system Process Risk Assessment and also Functional Risk Assessment. Contribute to the forum with facility process understanding and insight to identify the risk that could impact product quality and manufacturability. Therefore plan and implement mitigation actions.

Continues monitoring of the facility system in routine production. Troubling shooting from the perspectives of facility system, documentation, quality measurement (IPC), etc … to ensure the initially validated facility system continues meets quality and regulatory requirements.

Proactively contribute to the knowledge transfer between Roche Suzhou and CBRE IFM team on the related professional fields, give GxP relevant trainings to team members including CFDA/FDA’s rules for IVD industry.

To establish the purified water/clean steam/cold room validation procedure to align with AMS QMS schedule and requirement.

Lead the supporting work from CBRE for the PQ activities for facility relevant systems and closely with production/QA to deliver the qualified and reliable asset to be at operational level

Work with SAP team member to monitor/improve the validated system’s maintenance work through SAP system.

Take the internal auditor roles and responsibilities for GMP work compliance, report all the non-conformance issues and give related improvement action proposal and follow the actions afterwards.



Required Knowledge and Skills:

Ability to comprehend and interpret instructions, short correspondence, and memos and ask clarifying questions to ensure understanding.

Ability to write routine reports and correspondence.

Ability to respond to common inquiries or complaints from clients, co-workers, and/or supervisor.

 Ability to effectively present information to an internal department and/or large groups of employees.

Requires basic knowledge of financial terms and principles.

Ability to understand and carry out general instructions in standard situations. Ability to solve problems in standard situations. Requires basic analytical skills.

Intermediate experience in Microsoft Office Suite applications including: Word, PowerPoint, Excel, Visio and etc.

Good communication skills and strong self-motivation

Can work independently under pressure

Strong management skills and be flexible for different status

Ability to partner with demanding customers and servicing their requirements.

Proven interpersonal skills to develop effective working and trustful relationships with internal and external stakeholders.



Qualifications and Education :
Min. Bachelor’s Degree with engineering background, preferred in biochemical or pharmacy related industry and the working experience.

Min. 3 years’ experience in a highly regulated GMP manufacturing environment

Experience in qualification and validation within similar industry (IVD, Medical devices, Pharmaceuticals)

 Hands-on experience in maintain and improve facility system performance after validation completeness

Fluent oral/written English skills, can issue/present the English PPT

Understand basic SAP data input is plus 举报 分享

Full-service commercial real estate company in the world and we attribute this reality to the people who make our organisation.
CBRE offers an entrepreneurial environment that is dedicated to helping you set the pace in a rapidly changing marketplace. We have a culture that encourages and rewards creativity and innovation. We place a high value on ethics and set standards for excellence in service.
About CBRE in China
Our structure in in China ensures on-the-ground experience and a global service capability unequalled in the industry. In China, we have been operating since 1988, when the company was appointed as the leasing consultant to Tower One of the China World Trade Centre in Beijing. Since then, we have expanded our footprint to 13 offices throughout the country, as well as approximately 13 project offices and experience in over 100 cities across China.
CBRE’s commitment to enabling our clients’ to make the most informed real estate decisions requires a team of talented professionals who value their careers and want to be the best in their field.
At CBRE, the future is truly yours to shape.
我们是全球***的，提供全方位商业地产服务的公司，这些都归功于我们的员工们，是他们造就了我们的组织。
世邦魏理仕 提供富于进取的创业环境，致力于帮助您在快速变化的市场上领跑。我们的文化鼓励并嘉奖创意与创新。我们高度重视道德规范并设立了卓越服务的标准。
关于 世邦魏理仕 中国
我们在中国的架构保证了我们在业界拥有***的实地经验和全球服务能力。我们在中国的运营始于 1988 年，当时公司被委任为北京中国国际贸易中心大厦1座的租赁顾问。从那时开始，我们的业务已经扩展到全国 13家分公司，并拥有 13 个项目办公室，在全国 100 多个城市提供过服务。
世邦魏理仕 致力于让我们的客户作出最知情的房地产决策，这需要一个有才能的、重视职业发展并希望在自己的领域里出类拔萃的专业人士团队。
在 世邦魏理仕，您将拥有可自由挥洒的明天。