Accountability 职责
1. 验证 management system establish and maintenance:
验证和校准管理体系建设与维护：
a) Participate in validation management system establish: Establish validation management system according to the requirements of cGMP, reference to NMPA, EMA and FDA regulations.
参与验证和校准管理体系建设：按照cGMP要求，参照NMPA、EMA和FDA法规，建设验证和校准管理体系。
b) Participate in validation management system maintenance: Maintaining 验证 management system document according to cGMP requirements, reference to NMPA, EMA and FDA regulations to ensure system suitable and effective.
参与验证和校准管理体系维护：按照cGMP要求，参照NMPA、EMA和FDA法规，维护验证管理体系文件，确保体系的适用性和有效性。
c) Coordinate the resources of all parties, supervise and execute the validation activities.
协调各方资源，监督与管理确认和验证的执行。
d) Plan and manage the periodic validation of plant, equipment and facilities..
计划和管理厂房、设备、设施的周期性验证。
2. Project supporting
项目支持
Complete all 验证 activities in time to support company production and project delivery.
及时完成公司的所有验证活动，全力配合和支持公司产品的生产和项目的交付。
3. validation management
验证管理：
Participate in validation activities, include but not limited to validation deviation and change control, insure an efficient operational validation management system with full compliance with company policies, regulatory requirement and GMPs.
参与验证活动，包括但不限于验证偏差和变更控制,以确保高效的验证管理体系运营，确保完全符合公司政策、监管要求和GMPs。
4. Participate in Health Authority (HA) inspections
参与药监机构的官方检查：
Participate in Health Authority (HA) inspections (e.g., NMPA, USDA, EMA etc.), supporting inspection readiness at site as needed.
参与药监机构的官方检查（例如NMPA、USDA、EMA等），按需支持工厂迎检工作的完成。
5. Participate in self-inspection and external audit。
参与自检和外部审计工作。
Participate in self-inspection and external audit, ensure that there are no 验证 critical defects.
参与自检和外部审计工作，确保无关键验证缺陷项。
6. Any other tasks assigned by the leader.
完成领导交办的其他事项。
Job Requirements
任职要求
1. Basic understanding of regulatory requirement (NMPA, FDA and EMA etc.).
对NMPA、FDA和EMA等法律法规有基本的了解。
2. Practical experience in processes such as Deviation, CC, etc.
具有验证相关流程的实际经验，如偏差、变更等。
3. Own active skill and pressure resist capability in challenging present status, offering practical alternatives;
拥有有效的技巧及抗压能力以挑战现状，提供可行的解决方案；
4. Own the ability to develop and promote a creativity working environment;
能形成和促进具有创新和持续改进的工作氛围；
5. Have good understanding on manufacturing processes and unit operation;
对生产工艺和操作单元具有良好的理解；
6. Strong communication skills.
具有较强的沟通技巧；
7. Good business relationships.
能维护良好的业务关系；
8. Proficient with ordinary validation instrument.
能熟练操作各类常规验证仪器。
9. Ability to work effectively under pressure to meet deadlines, well organized to handle multiple tasks.
能够在压力下工作并按期达成目标，能够同时处理多种任务。
10. Minimum 3 years of biologic pharmaceutical experience with at least 3 years validation experience.
至少3年从事生物医药公司实践经验，其中至少1年的验证工作经验。
11. Familiar with pharmaceutical quality system, proficient with GMP 验证 requirement.
熟悉制药企业质量体系，熟悉GMP验证要求。
12. Fluent writing and reading ability in English.
流利的英语书写和阅读能力。
13. Pharmacy, Chemistry, Biochemistry and equivalent is preferred
药学、化学、生物化学及相关学科优先