职位描述
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:
- Handling OOS, event/deviation, change and CAPA related to identified area, such as operation, site service, QC and R&D etc. in RDSZ meets the regulatory (ISO13485, China GMP, FDA 21 CFR 820 etc.) requirements and the requirements from Divisional Quality Standard.
- The requirements are implemented effectively and elements of the identified areas (QC) in RDSZ quality management systems, and are continuously improved.
- The relevant quality assurance principles, e.g. concerning change control, deviation reporting, CAPA are implemented.
- Electronic Quality tools are used and maintained (e.g. Quality related functions in SAP, Deviation Database) and a trending of important Quality Metrics is carried out
Main Tasks & Responsibilities:
1. Assurance requirements in QMS related to identified area implementation - 30%
1.1 Review related procedures (QAP, SOP, instruction, specifications etc.) to assure the regulatory requirements from QA point view
1.2 If necessary, review record occasionally from compliance point view
2. Support on OOS, Deviation, Change Control & CAPA Management related to QC – 55%
2.1 Support local change board at AMS as to ensure compliance with internal (Roche Policies, Divisional Quality Standards) and external requirements (ISO 13485, IVDD, GMP, NMPA and AISA countries’ specific regulatory if applicable) within Operations and other QM-relevant processes.
2.2 Support change control IT tools (UniteD) RDSZ roll up, implementation and maintenance
2.3 Support coordination of Event/Deviation action and CAPA cases is done in accordance with the specifications.
2.4 Support product problem meetings (for the product portfolio) so that – in the event of product problems complaints – the respective CAPAs (corrective and preventive actions) are defined as well as being processed with the appropriate priority and implemented in due time, including a criticality assessment and possible
3. Employee Leadership – 15%
3.1 Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations
3.2 Set some of his/her own goals and tasks after discussions with line managers
3.3 Deal with complex problems in diverse range of tasks
3.4 Coach junior employee
3.5 Master the responsibility for the accomplishment of the business strategy and goals, moderate effects on
3.6 several departments or interests (customers, staff and environment)
Qualification & Requirement:
Education:
- A Bachelor's degree in Science (e.g. Biological Science, Biomedical or Chemical Engineering)
- Preferred: Master Degree
Experience:
- Have solid working experiences in quality assurance or quality control (chemical anylsis, microbial anlysis, biological analysi) with corresponding role for over 8 years
- Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development.
- Experience in working with the cross-functional teams.
- Planning and execution of tests and data transfer within IT-projects experience with audits.
Professional Competency:
- Knowledgeable in information technologies (IT)
- Competent with routine application of MS Office
- Experienced with the principles and system processes / tools of document administration
- Good language skills (written and spoken) in English; native language skills (written and spoken) in Chinese
- Responsible, trustworthy and sustainable
Roche is an equal opportunity employer.
