職位描述
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:
Responsible for on-line over sight, product release and systematic management thereof.
Main Tasks & Responsibilities:
1.Ensure product quality with online monitor – 70%
1.1 Setup online monitor management guideline and execute the online monitor to ensure QA oversight in operation process(including QC and warehouse) and environment monitor.
1.2 Identify potential quality risk during online process, support to make decision based on risk assessment.
1.3 Support shop floor to solve compliance related issue on time.
1.4 Maintenance online checklist and continuous improve on it. Monitor information from regulation and reflect to daily work, lead online improvement based on it, such as announced audit result, onsite audit result, etc.
1.5 Coach colleagues to deep understand the online rules.
1.6 Good collaboration within cross function team
2. Batch Record Review and Product Release – 15%
2.1 Execute batch record review tasks, follow QAP/SOP in RDSZ, maintenance all relevant interfaces with operation, QC within RDSZ and interface with corresponding QA organization outside of RDSZ from both process and SAP system
2.2 Perform Batch Record Review and Product Release tasks following de business process.
2.3 Support the document management process maintained in operation area.
3. System improvement – 5%
3.1 Monitoring of Periodic Review data in regards of Work Instructions, identify risk and highlight.
3.2 Maintaining and supporting improvement of temperature deviation process in SAP system
4.Audit support and others– 10%
Participate in internal and external audit process. Complete other tasks from line manager.
Qualification & Requirement:
Education:
- A Bachelor’s degree in Science (e.g. pharmacy, (bio-)chemistry, (molecular)biology, food and/or biotechnology)
- College or bachelor degree as minimum
Experience:
- Have solid working experiences in online monitor for 5 years+
- Have execution experience with SAP system, has test experience within IT-projects
- Experience with audits
Professional Competency:
- Good risk management skill
- Good communication skill with multi stakeholders
Roche is an equal opportunity employer.
