Job Description
Major Responsibility
- Manage routine supplier oversight activities, including site visits, case handling, and follow-up on complaints.
- Maintain and operate the Tracking and Serialization System, including but not limited to uploading and downloading tracking codes, as well as troubleshooting system issues.
- Prepare and update Quality SOPs; align procedures with regulatory and corporate requirements and ensure effective implementation.
- Monitor new NMPA regulations updates and provide consolidated and timely reports to the supervisor.
- Support and maintain the local Quality Assurance system to ensure compliance with requirements as DMAH
- Act as deputy QA responsible person and ensure compliance with corporate requirement.
- Provide training and support to relevant functions on quality-related regulations and corporate requirements.
- Receive and register GDP complaints related to transportation and temperature excursions; communicate with and provide feedback to complainants.
- Receive and register product complaints and recalls from the Chinese market in cooperation with the supervisor.
- Report and register suspected theft and counterfeit cases with Corporate Product Quality.
- Oversee the scrapping of products from the Chinese market.
Qualification
- At least bachelor's degree in pharmaceutical or biopharmaceutical sciences.
- At least 2 years' experience in GMP or GSP pharmaceutical company
- Good understanding of the pharmaceutical regulation in China
- Good command of English writing, speaking/listening skill and computer operation skill.
About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
Job Tags
Local area