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.
Main Tasks & Responsibilities主要工作職責 :
- Review of specification documents (eg. QAPs, Guidelines, AAs, SOPs) taking into account the factors influencing the participating functional areas (Quality, Regulatory Submissions, R & D, production, QC) and in accordance with the regulatory requirements.Deliver the training of QM Basic Course to organization.
- Facilitate quality relevant KPIs such as internal audit and external audit.
- Coordinate internal audit program, and ensure that the processing of audit CAPA cases carried out in accordance with the requirements, including:
- Preparation of internal annual audit plan
- Coordinate internal audit process
- Coordinate monthly internal auditor meeting
- Coordinate internal audit workshop
- Support coordinate authority/ notify body Audit essence of QMS AMS, including:
- Logistics preparation for external audit
- Documents readiness checklist and SME identification
- Audit room and war room set up
- Audit CAPA follow up
- Preparation of inputs for the Quality Management-Review; evaluation of Q-data as a basis for corrective and preventive actions.
Monitor Divisonal Standards(DS) and GSOP and coordinate gap analysis with related fucntions to ensure QMS system is in compliance with DS and GSOP requriements.
Qualification & Experience任職資格:
- University graduate (MSc) in one of the following fields: pharmacy, (bio-) chemistry, (molecular) biology; ph.D. Optional.
- ISO 13485 Auditor Certificate
- Knowledge of regulatory and legal national and international requirements such as ISO 13485, IVDD, GMP, CFDA and knowledge of internal processes and systems, chemical, technical and medical basics of products, the medical devices.
- Very good knowledge of English. Excellent communication skills.
- Familiar with relevant regulatory statutes and industry standards, Experienced with the principles and system processes / tools within the QA/QM field
- Familiar dealing with all level of authorities including China FDA officers, TUV auditors, Korea FDA officers, etc.
- Experienced in analysis of QA/QM processes, particularly with respect to compliance, efficiency and effectiveness
- Independent working style, well-experienced in organizational structures
- Proficient in communicating and presenting topics with business clientele
- Familiar with development, implementation and change processes
Roche is an equal opportunity employer.
