(Associate) QA Manager

Lundbeck View all jobs

  • Beijing
  • Permanent
  • Full-time
  • 9 days ago
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.
  • Good team player.

Lundbeck