Sr. QC Engineer - QC高级测试工程师
公司名称: 罗氏诊断产品(苏州)有限公司
部门名称: -
招聘人数: 1
发布日期: 2020-03-30
工作地点: 苏州-工业园区

岗位职责:


Who we are:

    

At Roche, 90,000 people across 150 countries are pushing back the frontiers of healthcare. Working together. Our success is built on innovation, curiosity and diversity.

    

As the worldwide market leader in in-vitro diagnostics, Roche is committed to providing the latest cutting-edge diagnostic solutions to advance the health and wellness of people worldwide. Roche Diagnostics (Suzhou) Ltd. was established in April 2015, with approximate investment of 450 million CHF and went into operation in end of 2018.

    

The new manufacturing site with a R&D center in Suzhou, China, addresses the growing demand for diagnostic tests in China and the Asia Pacific region; ensuring people have access to high-quality reagents, while providing a long-term sustainable contribution to meet the healthcare needs of the region.

    

    

Who you are:

    

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

    

Where a job title is not considered the final definition of who you are, but the starting point.

    

What we expect you could, as each colleague around you, aim high and think out of the box, embrace new changes and things with open mind. Confront challenges with passion and courage. Work with colleagues with integrity and keep up the good job.

    

    

Job Summary:

    

-      Responsible for safe, reliable, cost-effective and efficient operation of the test group of Clinical Chemistry in QC

    

-      The job holder ensures to meet / perform

    

-      General

    

-      Technical

    

-      Safety, Health & Environment

    

-      Material and product release

    

-      Continuous Improvement and Innovation

    

Main Tasks & Responsibilities:

    

General

    

-      Complete assigned test tasks and activities within group and lab to fulfill operation in site

    

-      Report unstable issues that happened during test

    

-      Make sure all the activities are all in compliance with QAP/SOP/Global & local authority requirements

    

    

Technical:

    

-      Perform raw material, IPC and final release tests independently according to latest TPs, TIs and TSs.

    

-      Ensure reliable analytical laboratory operations for Clinical Chemistry and related raw materials, e.g. equipment, document, test methods, etc.

    

-      Cooperate closely within QC department and other functions in RDSZ to solve product and material issues

    

-      Plan/implement optimizing Global operation QC test process and labor efficiency projects to make the operation in lab more meeting with required safety and quality levels

    

-      Implement continuous improvement of activities in lab and procedures

    

-      Monitor products performance by use data in a scientific way to support improvement of product quality through the site

    

    

Safety, Health & Environment

    

-      Ensure all applicable SHE requirements been fulfilled to comply with corporate group policy and local regulations

    

    

Material and product release:

    

-      Planning and monitoring of IPC and product release test status

    

-      After performing test every time, responsible for doing test record and reviewing to ensure test data accuracy, timeliness, and data traceability for each test.

    

-      Supporting in investigation and test analysis for raw material and product issues from internal process and market

    

-      Participate in supplier localization project in supplier selection/evaluation, specification transfer and initiation, material validation and quality agreement as well.

    

-      Take part in ClinChem products’ specification creation, on site type test, stability study and documentation to support product registration in market

    

    

Continuous Improvement and Innovation

    

-      Implement continuous improvement projects and activities

    

-      Support innovation by need

    

    

Education:

    

College Degree or more in Chemistry or Clinical biochemistry or Biochemistry or Pharmacy or Biological Engineering

    

    

Experience:

  • At least 5 years’ experience for bachelor’s degree in the required functional area
  • At least 3 years’ experience for master Degree in the required functional area
  • Related work experience in the Diagnostics, Pharmaceutical Industry with the field of QC, IPC and R&D related
  • Basic understanding of the QC

                    

    

Professional Competencies:

    

?     Professional and positive approach

    

?     Diligent with attention to detail

    

?     Ability to cope with ambiguity and pressure

    

?     Collaborates well, while also is capable of dealing with conflict resolution

    

?     Dynamic and vigorous

    

?     Self-motivated & self-sufficient

    

?     Effective communicator at all levels

    

?     Ability to convey concepts to different management levels and across functions within the organization/project

    

?     Team player with the ability to work on their own initiative

    

?     Assertive, adaptable and creative

    

?     High cultural awareness and proven ability to work with a broad range of cultures

    

?     Ability of systematic, interlinked and analytic as well as strategic thinking

    

?     A “can-do” attitude and willingness to go the extra mile when required

        

    

Roche is an equal opportunity employer.

    







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