At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Roles & Responsibilities
● Ensure business in compliance with the requirements of China GSP and SOPs.
● Responsible for quality issue in business activities to make sure the quality system under continuous and effective operation.
● Responsible for implementation of Quality objectives in department.
● Support for comprehensive, continuous and effective operation in quality department.
● Guide all the departments and staff to implement the Drug Administration Law and Good Supply Practice (GSP) Regulation of drug and medical device.
● Support quality related work in business activities.
● Support for local HA GSP inspection of drug and medical device.
● Support for PTQ and DMAH audit.
●Support for drafting, revising the SOPs of quality department.
● According to the quality policy and objective, ensure the achievement of department objectives.
●Support for handling PE and UPE as owner in operation.。
●Support for risk assessments in GSP operation.
●Support for the internal inspection and complete corrective actions.
●Support for supervise 3rd party logistics service provide related quality work
●Support for 3rd party logistics service provide annual quality audits.
● Responsible for confirmation and dealing with the unqualified products.
● Responsible for temperature assessment before goods receiving for importing products。
● Responsible for checking the release documents for every batch and finial release of qualified products.
● Responsible for timely reporting to Shanghai monitoring platform for purchasing, selling information.
● Support for QMS implementation in RSPT.
● Support for RSPT training management.
●Support for the collection and feedback on quality information.
● Support for the investigation of quality accidents processing and report. according to GSP regulation.
●Support or reporting counterfeit pharmaceuticals according to GSP regulation.
Support for recall management according to GSP regulation. Support Mock recall
Support for T1 quality management.
Education/Qualifications
● Academic requirement:
Bachelor degree or above
Pharmacy, Chemistry, Biochemistry and equivalent disciplines
● More than 5 years of pharmaceutical quality management
● Licensed pharmacist（priority）
Job Required Competencies
● Good accountability of GSP understanding and implementing.
● The ability to correctly judge and ensure the implementation of quality management.
● Knowledge and experience in company operation and quality management.
● Well communication skills and good accountability of problem solving.
● Language skill: Good at English, listening, speaking, reading and writing.
● Office skill：Win-word, Excel, PowerPoint
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.