Implement GMP compliance with global GMP standards and China GMP requirement
根据总部和中国GMP要求，执行GMP符合性工作
● Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirements
确保QC的质量标准和分析方法符合相关药典要求
● Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods.
确保QC的质量标准和分析方法和CMC注册文件一致。
● Support Chinese Pharmacopeia commenting and implementation across the network
支持中国药典在集团内的意见反馈与执行
● Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reports
维护验证主计划，及时执行方法验证计划和报告。
● Excute analytical transfers and local analytical method verifications.
执行分析方法转移和本地分析方法确认。
● Provide technical guidance on test methods and relevant procedures.
对测试方法和检测过程提供技术支持。
● Provide QC technical support and oversight to CMO activities
对CMO活动提供QC技术支持和监督
● Support regulatory inspections and partner audits
支持官方审计和合作伙伴审计
● Sample receipt, storage, distribution and disposal procedure management.
样品的接收、存储、分发及处理流程的管理。
● Reference and retention sample management.
参考留样及常规留样的管理。
● Packaging material standard sample management.
包材的标准样管理。
● Reference standards management
标准品管理
● Third party QC labs management
第三方实验室管理。
● Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing.
确保支持生产过程中的故障排除和其他的产品生命周期测试。
● Manage the trending process in labs according to Roche PQS requirements and regulations
根据罗氏PQS和法规要求，管理实验室的趋势分析流程
● Stability program - chamber management, coordination with global and laboratories for timely execution of stability protocols and stability report, stability trending
稳定性安排-箱子管理、协调总部和实验室以保证稳定性方案、报告以及稳定性趋势分析的及时执行
● QC metrics generation and report, managing performance of quality system processes (TCM, Discrepancies, CAPA, etc) for QC
QC量度的生成及报告，管理QC相关的质量体系（变更、偏差、CAPA等）的指标
Qualifications and Experience
● Bachelor's Degree and above (Pharmacy, Master's Degree is preferred)
本科及以上学历（药学，硕士以上学历优先考虑）
● More than 3 years pharmaceutical or related company
三年以上医药及相关领域工作经验
● Excellent verbal and written English skill
出色的英语口语及书面能力
● Excellent project leading experience
出色的项目管理经验