岗位职责:
1. 管理和技术支持
1) 协助QC经理/QC副经理监督并确保QC实验室内的精密仪器检验相关的日常活动符合公司要求和GMP指南；
2) 管理原材料、在制品和成品中涉及的精密仪器项目及时检测并提供记录数据；
3) 协助管理层调查精密仪器相关项目OOS情况；
4) 监督稳定性活动，根据检测计划在规定时间内完成精密仪器相关检测，确保符合监管要求；
5) 安排、规划、执行并确保完成分配精密仪器（例如HPLC,GC，ICP-MS）相关的验证和任务。
2. 建立程序和标准
1) 协助建立原料、中间产品和成品的标准操作程序、方法和标准；
2) 开发验证和确认文件，如方法验证方案、URS、DQ、IQ、OQ、PQ 等。
3. 测试或检查/其他
1) 进行方法开发和验证；
2) 进行设备确认；
3) 根据检验计划和标准，对原料药、辅料、包装材料、中间产品和成品进行化学和物理测试；
4) 进行设备校准和维护；
5) 制备实验室使用的溶液，包括试剂、流动相、酸和碱；
6) 解释和报告分析结果；
7) 根据cGMP准确撰写文件；
8) 妥善处理和处置化学品；
9) 保持实验室清洁；
10) 分配的其他职责。
1. Management and Technical Support
a) to assist the QC Manager/ Deputy QC Manager in overseeing and ensuring the running of all day-to-day activities related to the inspection of precision instruments in QC laboratory in compliance with company requirements and GMP guidelines;
b) to manage timely testing of precision instrumentation involved in raw materials, in-process and finished goods and provide recorded data;
c) to provide assistance to management in investigating OOS conditions of precision instrument related projects;
d) to supervise stability activities and complete precision instrument related tests within the specified time according to the test plan to ensure compliance with regulatory requirements;
e) to schedule, plan, perform and ensure that the assigned assigned precision instrumentation (e.g. HPLC, GC, ICP-MS) related validation and tasks are completed.
2. To establish procedures and specifications
a) to assist in establishing Standard Operating Procedures, method and specifications for starting materials, intermediate and finished products;
b) to develop validation and qualification documents such as Method validation protocol, URS, DQ, IQ, OQ, PQ, and others.
3. Tests or examinations/Others
a) to perform methods development and validation;
b) to perform equipment qualification;
c) to perform chemical and physical tests on APIs, excipients, packaging material, intermediate and finish product as per inspection plans and specification requirements;
d) to perform equipment calibration & maintenance;
e) to ensure the standards are prepared, continuously available, properly stored;
f) to interpret and report results of analysis;
g) to complete documentation accurately and according to cGMP;
h) to properly handle and dispose of chemicals;
i) to maintain the cleanliness of laboratory;
j) Other duties as assigned.
任职要求:
1. 所需教育和经验
1) 化学/应用科学/药学或相关专业学士及以上学位。
2) 至少3年制药QC实验室或 HOKLAS 实验室工作经验。
2. 知识和技能
1) GMP、GLP、GDP、实验室安全、洁净更衣技能、取样技术、标准实验室设备的使用和维护、实验室方法和技术、处理危险药物和受控物质的方法和程序。
2) 熟悉常用实验室设备。此外熟悉HPLC、GC、ICP-MS溶解测试仪、崩解测试仪等。熟悉配备专业软件的电脑操作。
1. Required Education & Experience
a) Bachelors degree or above in Chemistry / Applied Science/ Pharmaceutical Study or equivalent.
b) Experience: Minimum 3 years practical experience working in a pharmaceutical Q.C. Laboratory or HOKLAS Laboratory.
2. Knowledge and Skill (Optional)
a) GMP , GLP , GDP, Laboratory safety, Gowning techniques, Sampling techniques, Uses and care of standard laboratory equipment, Laboratory methods and techniques, Methods and procedures for handling Dangerous Drug and Controlled substance.
b) Usual laboratory equipment. In addition: HPLC, GC, ICP-MS, Dissolution Tester, Disintegration Tester, etc. PC with specialized software.