苏州招聘

Education / Experience
1.University degree or above in Chemistry, Food Science / Pharmacy or related discipline.
2.Minimum of 1 years of industrial Quality Assurance experience in Food / Nutritional / Pharmaceutical / Manufacturing industries.
Special Knowledge
1.The knowledge and experience of GMP and GLP is required.
2.Rich experience in equipment 3Q activities and test method validation.
3.Experience in incoming check of raw / packaging material and in-process quality control is preferred.
Skill
1.Good verbal and written communication skills in both Chinese and English
2.Good analytical and interpersonal skills. Proficiency in computer applications relevant to the job
3.Able to work on rotating shifts
教育/经历
1、大学或以上学历（化学、食品科学/食品工程，或相关专业）；
2、在制药、食品或营养品行业有至少一年以上的生产运营质量保证方面的工作经验。
特殊知识
1.须具备GMP和 GLP方面的知识和经验；
2.丰富的实验室仪器3Q 认证和方法验证的经验；
3.有原、包装材料质量检测和在线质量控制经验的优先。
技能
1.良好的汉语和英语的口头和书面的沟通技能；
2.良好的分析和交际技巧，熟练运用计算机办公软件；
3.能够倒班/轮班工作。

1.Be knowledgeable with applicable Level I and II policies, procedures and guidelines. To ensure continuous compliance to GMP in designated areas of responsibilities.
2.Responsible for assisting to establish, follow, and continuously improve quality system in lab.
3.Be accountable to initial and review equipment qualification protocol, and finish it by himself or herself, or help inspector with Qualify, Operate, calibrate and maintain laboratory facilities and instrument as schedule and procedure requirement.
4.Be accountable for initialing or reviewing method validation/transfer protocol, implement, and finish summary report , assist in the development and review of laboratory test methods.
5.Study and grasp the manufacturing, technical specification of incoming material, and its possible quality flaw, and the possible impact on finished product.
6.Grasp the related production technology, parameters and operational procedures. Responsible for the investigation of in-process deviation.
7.Sampling of in-coming materials and in-process material (finished goods, bulk and product complaints) according to relevant sampling plans or as per supervisors’ direction.
8.Test, inspect and feedback results promptly, when necessary to operations
9.Responsible for own training records and only conduct assigned duties with proper documented training records.
10.Responsible for the accuracy, integrity and reliability of all lab data generated.
11.Maintenance and implementation of raw material and finished product retain program.
12.Carry out supporting activities for proper operations of the lab according to defined protocols – calibration, housekeeping, preventive maintenance etc.
13.Adhere to job schedules.
14.Execute all duties faithfully and responsibly in accordance to written procedures and to immediately report all observations of GMP non-conformances.
15.Assist in any other duties as assigned by the Supervisor
16.Assists in the administrative functions of ensuring lab supplies are properly replenished and managed without incurring delays of result release.
17.Responsible for the exercising of maximum care, good judgement and behavior in preventing EHS incidents.
18.Assist in the training of new inspector so as to enable them qualified to carry out their duties. Be accountable to implement new test method and qualify other person.
1.掌握相关适用的一级和二级政策、程序和指导文件，以确保在职责区域内GMP的持续符合性。
2.负责协助建立、维护和完善实验室的质量体系。
3.按照时间表和规程要求，负责设备3Q方案的起草和审核，协助检查员完成实验室公用设施和设备的确认、操作、校验和维护工作。
4.负责实验室检测方法转移或验证方案的起草或审核、分析、及完成总结报告，协助开发和审核检验方法。
5.研究和掌握与原、包装材料相关的生产、技术指标和其可能的质量缺陷及对成品的影响。
6.掌握相关的生产工艺、参数和操作规程。负责在线偏差调查。
7.依据相应的取样计划或依据主管安排对原、包装材料和在线（半）成品取样。
8.在必要时及时地测试检查并反馈结果。
9.负责完成自己的培训记录，仅执行已培训合格的工作内容。
10.负责所有实验室产生的数据的精确度、完整性和可靠性。
11.维护和执行原材料和成品的保留样程序。
12.依据既定的校正、清洁和预防性维护等计划，为实验室的正常运作执行支持性工作。
13.遵守工作计划安排。
14.依据书面规程忠诚尽职地工作，并立刻报告所有不符合GMP的情况。
15.上级指派的其它工作。
16.协助管理者确保实验室供给的补充和管理，而不会拖延结果放行。
17.在预防EHS事故方面，有责任在操作时具有最大限度地小心、好的判断和行为。
18.协助新入职检查员完成培训，使之能够合格并履行他们的职责。负责新方法的实施和检查员可否从事该项检测的资格认定。

简历接收邮箱：HRrecruit.suzhou@wyethnutrition.com

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