罗氏促进多元化、公平性和包容性，代表我们所服务的社区。在全球范围内处理医疗保健问题时，多元化是成功的关键因素。我们认为，包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性，共同抱持对卓越护理的热情。加入罗氏，每个声音都会得到重视。
职位
Overview
* Represents design quality in product transfer/development to achieve
sustainable compliance of projects.
* Provides design quality support with a pro-active, business solution
oriented approach, while collaboratively being involved in the generation,
review deliverables during product transfer/development.
* Proactively related regulation assessment for design and development part
from quality perspective.
* Ensures that any design quality issues that may jeopardize the regulatory
status of the projects and products in their work area are handled with the
necessary priority and urgency.
* Ensure that the process is complies with the requirements of European, US,
China and International cGMP regulations and the requirements from Roche Global
Standard Process or Divisional Quality Standard.
The What
* Perform activities as required to meet Q&R goals and objectives
independently. Able to identify improvements and implement with collaboration
from supervisor. Navigates in complex situations by applying a diverse skillset.
* Prepare documentation for and participate in audits as applicable.
* Document authoring and review as required to support changes. Performs
technical reviews, as applicable. May require collaboration with supervisor on
technically complex technical reviews independently.
* Complete all required training in learning solution.
* Responsible for training, coaching and mentoring other quality managers or
business partners, as applicable in a professional manner to ensure that
business needs are being met.
* Able to troubleshoot issues as they arise, develop and independently
implement solutions to ensure that daily work is completed without jeopardizing
compliance.
* Ability to work day to day with minimal to no supervision to correctly
complete daily scheduled and unscheduled activities. Initiates activities
independently and initiates interactions across departments as applicable.
Initiates daily activities independently. Has courage to make decisions even
outside of scope/comfort zone. Is decisive and does not procrastinate on
decisions; develop solutions and presents both issues and solutions to
supervisor.
* Identify, Initiate, facilitate, participate and implement process
improvements to meet business needs. Able to link responsibilities with both
site and Global Quality and Regulatory. Drive innovation across the local
organization/site.
The How
* Know and follow the We@Roche Diagnostics Dimensions and Roche Core
Competencies. Adopts and adheres to the Leadership Commitments. Accountable for
meeting commitments. Is flexible able to shift priorities while balancing
commitments and daily work requirements, independently. Seeks candid feedback
on his or her performance and acts on it. Recognizes the contributions of
teammates and peers. Establishes strong collaborative relationships
inter-departmentally and across the sites and leverages these connections to
achieve our key results. Identifies personal goals and actively manages her or
his career to pursue personal goals and priorities independently.
The Impact:
* We employ talented people and expect great things from them. Contributions
are delivered in a way that lives up to our commitments to each other and the
We@Roche Diagnostic Commitments. Build and develop your capabilities to
contribute more to the team, local and global organization, customers and
patients. Apply new ways of enhancing your work to drive approaches that
increase productivity, reduce costs or mitigate significant compliance issues
within your area of influence as well as across sites and all of the global
functions. Works as a strategic business partner to help break down silos
between organizations (internal and external) all which lead to developing and
producing safe, quality products and services that meet customer requirements
throughout the entire lifecycle. Push the boundaries to enable, develop and
drive smart, risk-based compliant processes that result in quick and efficient
innovation.
Main Tasks & Responsibilities:
* Support to maintain quality management related procedure in design and
development and provide quality opinion from compliance view.
* Participates in the reviewing of deliverables and milestone review meeting,
and present as a quality representative for new development/product transfer.
* Supports external and/or internal audits and inspections based on the
business needs.
* Tracking and interpreting external requirements regarding design and
development aspect and making recommendations for implementation.
* Skilled in thinking interdisciplinary; creating confident and open
relationships within all organizational levels, specifically within matrix
organizations.
* Deal with complex problems in diverse range of tasks.
* Coach junior employee.
* Other tasks assigned by line manager.
Qualification & Experience:
* A Bachelor’s degree in Life Science, pharmaceutical engineering or related
subject.
* Competent with routine application of MS Office.
* At least five (5) years in the Medical Device/Pharma/Biopharmaceutical
industry.
* Has worked in more than one function within quality management and may have
worked outside of Quality Management. Can managing highly complex and/or
global projects, or equivalent experience.
* Knowledge of the European, US, China and International cGMP regulations.
* Good in communication and report writing in Chinese and English.
我们是谁
在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。
罗氏提供平等的职业发展机会。