上海招聘

JOB DeSCRIPTION职位描述

I. Essential Functions基本职责:

The position is responsible for ensuring the sufficient/proper incoming, finished product tests, performing test method transfer/validation and test instrument validation, plant environmental monitoring program to management improving good lab practices and managing lab staff.

此职位负责确保足够/正确的来料，成品检验执行测试方法转移/验证和测试仪器验证工厂环境检测项目来管理改进良好实验室规范和管理实验室员工。

II. Specific Duties, Activities, and Responsibilities特殊职责，职能任务:

Responsibilities职责:

· Management site QC lab, ensure the laboratory is operated effectively and efficiently with regards to timely testing.

管理工厂QC实验室确保实验室有效和高效地运行，及时完成各种测试任务。

· Development and maintain the relationship with TPL/regulation authority lab.

发展和维护与第三方实验室，监管机构实验室的良好关系。

· According GLP/5S/EHS compliance in QC lab.

QC 实验室依照GLP/5S/EHS合规

· Work with related department （including RD, RA, QA, production etc.） to develop material specification

与相关部门(包括RD,RA,QA,生产等)开发物料的技术标准。

· Ensure testing accord to defined standards/policy and adherence to GLP. Review the test records, ensuring test accuracy and good documentation practice performed. Organize testing trouble-shooting and problem solving.

确保测试依照规定的标准/方针和根据GLP原则。审核检验记录，确保测试的精确性和良好的文件记录规范执行，组织测试问题讨论和问题解决。

· Supervise to maintain sufficient/adequate stock of regents, media and glassware，consumables etc. Supervise calibration in lab.

管理实验室试剂，培养基，玻璃器皿，消耗品仪器的库存，管理实验室仪器的计量校正。

· Work with related people in test method and test instrument validation, and test method transfer. Responsible for the introduction of new methods of analysis, technologies, validation protocols and the criteria approach for methods of analysis. Organize the training if need

与相关人员合作进行测试方法，测试仪器的验证以及分析方法的转移。负责新的分析方法，技术和验证方案，以及分析方法的建立程序制定。根据需要组织培训。

· Develop and maintain plant environmental monitoring program, conduct hazard analysis from microbiological perspective, give positive ideas to prevent micro contamination and improve hygiene status through plant site.

开发和维护工厂环境检测项目，执行微生物危害性风险分析。对整个工厂的微生物污染预防和卫生改善提供积极的意见。

· Manage and improve incoming acceptance program, sampling, testing, and released on time. Manage retention sample program.

管理和改善进货接收检验流程，及时取样，测试和放行，管理留样程序。

· Review all laboratory OOS, deviation investigation and CAPA to ensure completeness and thoroughness. Ensure related CAPA effective implement. Support supplier issue investigation and CAPA plan setting if applicable.

审查实验室的OOS，偏差调查和CAPA， 确保完整性和彻底性。确保相关CAPA有效执行，支持供应商问题的调查和CAPA计划实施（如果适用）。

· Continue improve lab testing capability, well organize the testing, optimize test method, control testing time and cost.

持续提高实验室的检验能力，合理安排检验，优化检验方法，控制检验时间以及检验费用。

· Manage and train up employees reported to him/her, and give sufficient and prompt support to them. Encourage employees under his/her supervision to submit Near Miss reports and other opportunities to improve the lab management.

管理和培训下属员工，给予他们足够的支持，鼓励下属员工汇报NEAR MISS和其他问题来改进实验室的管理。

· Take extra tasks/works assigned to him/her by site Quality Head.

领导分配的其他工作任务。

III. Position Requirements职位要求:

Education or Equivalent教育或同等学历: (Minimum required to perform job工作的最低要求)

· Bachelor degree or above in chemistry, food, or related.

本科以上学历，化工，食品或其他相关专业。

· At least 5 years extensive experience in Food, Nutritional or Pharmaceutical manufacturing Lab is preferred.

食品，营养品，或者制药工厂实验室5年以上相关工作经验。

Knowledge/Skills Requirements知识/技能要求:

· 8 years or above Lab experience with 3 years management experience.

8年以上实验室经验，3年以上管理工作经验。

· Familiar with GLP/GMP, if have experience of ISO17025 that is prefect.

熟悉GLP/GMP，有ISO17025相关经验则更好。

Catalent Overview

We are a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development to patient.
With over 85 years of experience in the industry, Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. We became a publicly traded company (NYSE: CTLT) in 2014 and have grown to become a vibrant community of more than 11,000 employees supporting over 7000 products for over 1000 customers all around the world. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.
Currently, Catalent has invested in two facilities in Shanghai, China, located in Waigaoqiao FTZ and Pudong Tangzhen, is near by China’s Zhangjiang Pharma Valley area. The two clinical supply centers will work together to provide a comprehensive range of clinical supply services to clients in China, Asia Pacific and around the world.

Catalent. More products. Better treatments. Reliably supplied.™

For more information please visit our website ****************


康泰伦特概览

我们是临床研发和给药技术的全球领导者，从药物研发，商业化生产到全球服务，我们的技术和服务贯穿于产品的整个生命周期，配方前期研究到生产供应的每一个阶段，我们都能提供完善的方案服务，助力提供更好的产品疗效，让每个人的生活更健康，更精彩。
康泰伦特拥有85年的行业服务经验，每年支持我们的合作伙伴推出200+新产品，超过700亿的年产量。康泰伦特是一家朝气蓬勃的公司于2014年上市并发展成为在全球拥有11,000名雇员，为全球1000多家客户提供7000多款产品。在康泰伦特我们的核心价值观是患者***，在全世界范围内，运用专业知识和先进技术和客户合作提高和改善患者生活。
目前，康泰伦特已在中国上海投资了两家临床供应中心，分别位于外高桥保税区和毗邻张江药谷的浦东唐镇，满足客户国内外临床试验的差异化需求。两家临床供应中心将共同协作为中国、亚太以及全球客户提供全面广泛的临床供应服务。

康泰伦特。更多的产品。更好的治疗。可靠地供应。™

获取更多信息请浏览公司官网 ****************