QA Specialist (Manager)
|QA Specialist (Manager)|
The purpose of this QA officer role is to have quality oversight to FTZ operation to determine that systems, facilities and written procedures are in compliance with GMP/GSP and Lilly global quality standards and followed in order to assure that operations are in control and products meet, throughout the whole processes, all the applicable specifications. Periodic audits are conducted with the operations against applicable regulations and Lilly standards to determine that procedures and systems are suitable to oversight of operations and action plans required to address observations resulted from audit.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1. 保证质量体系符合礼来GQS及相关法律/法规的要求，确保对产品的任何操作均不影响产品的 质量。
To ensure local Quality System for Lilly China Marketing Affiliate is compliance with the requirements of Lilly GQS and local regulations, and be sure there is no impact on Product Quality.
2. 负责对礼来的进口产品进库检查 和放行。
To be responsible for product verification and release on incoming products in bonded warehouse.
3. 负责处理 促销材料的管理
To be responsible for promotional material management.
To be responsible for GMP Service Providers quality management.
As the main Regulus Document Controller (DC), maintain good documentation system.
6. 负责进行产品相关的偏差 调查和处理及变更管理, 符合GQS。
To be responsible for conducting the investigation and handling of deviation related to the
Imported product， and change control to meets the requirements of GQS.
To be responsible for product customization, prepare and update and maintain Packaging Order, SPI, etc.
To be responsible for prepare monthly relevant Affiliate Quality Metrics and quality Management Review annually.
|Minimum Qualification Requirements: [List requirements for education, experience, skills and any required certifications. See examples below.]
Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences
Three years of QA experience in drug product distribution/ wholesaler and GSP knowledge.
Capable of listening, speaking and writing in English in fluency
Other Information/Additional Preferences:
Excellent communication (written and verbal), organizational and negotiation skills, self-motivated and proactive.
Strong knowledge of quality systems