Position Description:
职位描述：
This JD is for skilled QC Technician, who currently focusses on lab activities about sampling (raw materials, API, FP, packaging materials, etc.), routine tests (raw materials, API, FP, stability products, packaging materials, wastewater, etc.), lab equipment calibration and maintenance.
QC技术员的主要职责有：样品的取样（原辅料、活性成分、成品、包材等），日常的测试（原辅料、活性成分、成品、稳定性样品、包材等），实验室设备的校验和维护。
For long-term development, who will focus on method validation & verification & transfer, lab equipment qualification and maintenance, analytical method and SOP updated, routine tests (API, raw material, FP, stability product, etc.)
长期的发展方向：分析方法的验证、确认和转移，实验室设备的确认和维护，分析方法和实验室SOP的更新，以及日常的测试（原辅料、活性成分、成品、稳定性样品）。
Functions, Duties, Tasks:
职能、职责、任务：
- Responsible for sampling and carrying out testing for raw materials, API, FP, packaging materials, stability products, etc. Ensure to complete incoming analytical requests accurately and timely.
- 负责取样和执行原辅料、活性成份、成品、包材、稳定性样品等的测试，确保接收的物料能够及时的完成测试。
- Support with an analytical comparison test between Wusi and the supplier for new supplier qualification.
- 支持供应商的比对测试
- Support to complete the analytical method validation & verification & transfer.
- 支持分析方法的验证、确认和转移工作
- Ensure QC lab safety and Personnel Protective Equipment is used in the lab area.
- 确保实验室内设备和个人防护的正确使用
- Finish other tasks assigned by Supervisor.
- 完成主管布置的其他任务。
- Development Plan 发展计划：
- Participate in establishing testing methods for product, raw materials and packaging materials, and relevant SOPs according to given instructions, ensure to comply with GMP, regulatory and Elanco requirements.
- 参与成品、原辅料和包材分析方法的建立，并能根据提供的说明建立相应的SOP，确保符合GMP及Elanco内部要求。
- Take part actively in correction to the observations found in self-inspection and Official audit.
- 参与完成内审或官方检查而出现的整改项
- Lead OOS Investigation
- 执行实验室调查
- Responsible for analytical method validation & verification & transfer
- 负责分析方法的验证、确认和转移
- Execute lab equipment calibration (daily) and maintenance, ensure to perform all tests smoothly.
- 执行设备的校验/确认/维护，确保设备维持良好的运行状态
Minimum Qualification (education, experience and/or training, required certifications):
任职资格要求（教育、经验和/或培训，必要的证明）：
- College degree or above, major in pharmacy, veterinary medicine, biology, chemistry or related.
- Or engaged in analytical work for more than 3 years of (or above) secondary school or high school education.
- 或从事检验工作3年以上的中专、高中以上学历
- Prior experience as QC analyst for API manufacturing and formulation is a plus.
- 有药企工作经验者优先
Additional Preferences:
额外优先条件：
- Functional /Technical skills: Has the functional and technical knowledge and skills to do the job.
- 职能/技术技能：具备职能所需的技术知识
- Witten communication: Is able to write clearly and succinctly.
- 沟通能力：写作能力良好
- Quality Management – Cross- Functional
- 质量管理---跨部门沟通
- Integrity and trust: See as a direct, truthful individual; doesn’t misrepresent him/herself for personal gain.
- 正直和信任：为人正直，诚实。
Other Information:
其他信息：
- Familiar with MS Excel and Word. 熟练运用办公软件
- Communication skills 良好的沟通能力
- Knowledge of cGMP, working knowledge of safety. 具备一定的cGMP知识，具有安全意识
- Location: Wusi site 工作地点：五四工厂