天津招聘

Principal Duties and Responsibilities

1. Participate in the daily activities of the QA Department as assigned.

2. Estabilish and maintain quiluty system to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements.

3. Lead or participate in the internal auditing program for JHL Wuhan China, as required. Also supporting regulatory, client and third party supplier auduts.

4. Lead or partifcipate in the execution of the product compliant system and assist with product return, withdrawal or recall activities. as required.

5. Oversee compliance ofthe environmental monitoring and validation program.

6.Operational execcution of key elements of the quality system-including document control, change control, discrepany and CAPA, to maintain compliance with GMP andinternational regulatory requirements.

7. Writing or reviewing completed quality system documents.

8. Provide QA input on GMP facilty and GMP utilities issues such as qualifications/requalification, changes, maintenance,startup/shutdown, disaster recovery.

9.Writing or reviewing validation validation protocols such as IQ, OQ and PQ to support new production equipment installation.

10.Review and approval of data for determining the disposition of GMP material(raw materia, in-process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the stability program.

11. Conduct GMP traning for internal functional department.

Job Requirements.

1. BS degree, scientific discpline preferred.

2. At least 5 yearsexperience in a quality regulated industry, pharmaceutical or medical device experience is preferred, QC experience and regulatory submission experience in China is a plus.

3. At least 2 years in a GMP quality system QA role.

4. Proficiency in the use of all microsoft office applications.

5.Demonstrated leadership experience with personnel management, developmentand accountability

6. Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meat deadlines. Well organized and detail oriented professional.

7. In-depth knowledge of GMps and related guidelines and redulatory requirements.

8. Good oral and written communication skils in English and Mandarin. (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within quality assurance and multi-disciplinary teams.

    喜康生物由凯鹏华盈、红杉资本、柏乐创投、台湾中华开发工业银行率先出资建立。在喜康生物成立后的第二年，即2014年，台湾统一集团、富邦投资等台湾多家财团继续跟进投资完成B轮近3500万美元的融资。2015年3月，喜康生物完成C轮增资，本次募资金额达4560万美元，投资者包括管理资产额超过1.6万亿美元的全球知名的交叉基金麦顿投资、元生创投和利域投资管理公司。公司自成立以来，已成功募集超过1.35亿美元资金。2015年9月，喜康生物成功登录台湾资本市场。2016年2月25日，喜康与美国通用合作建立的全球首个符合国际标准的模块化大分子生物制药工厂（KUBioTM）建成并正式投入运营。2016年12月份，法国赛诺菲与喜康生物达成战略合作伙伴关系。
    公司主营业务是为国际国内医药企业提供抗体药物研发及生产代工服务。成套引进国际抗体生产设备和质量管理体系，实现美国FDA和欧盟EMA标准认证。公司定位于治疗性抗体药物研发和产业化转化，为国际国内客户提供抗体工程细胞株筛选、培养基培养工艺优化、纯化制备工艺优化、工艺放大、质量研究和质量标准制定、临床前、临床研究样品制备及终端上市产品的生产、符合美国和欧盟的质量管理体系等内容的合同外包服务。
    喜康（武汉）生物医药有限公司的核心技术团队均来源于基因泰克（Genentech）、罗氏（Roche）以及辉瑞（Pfizer）等全球***生物医药领军企业服务背景，曾领导了多个重磅生物抗体药的研发与生产，尤其在抗体药大规模生产技术方面积累了领先于行业的宝贵经验。
    喜康生物目前在台湾新竹建设有符合国际标准的抗体药物研发及中式基地。2016年2月位于武汉光谷生物城的符合国际标准的模块化大分子生物制药工厂正式投入运营。喜康生物研发及生产的rituximab生物类似药（学名中译：利妥昔单抗）于2016年2月获得英国药监局核准，将在欧洲进行用于类风湿性关节炎病人之临床一期试验，成为一家获准在欧洲进行单克隆抗体生物类似药临床试验的生物制药公司。
    2013年9月25日，美国通用电气（GE）正式在全球新闻发布，将为JHL公司在中国光谷生物城建设KUBio模块化生物制药工厂。KUBio不同于中国传统的生物制品厂的建设，它是一种建设生物制药工厂的全新方法，可在14-18个月内为客户提供功能齐全，可直接投入生产的生物制药工厂，相对于传统工厂，大大缩短了建设周期。KUBio 完全按照cGMP的验证要求设计，能帮助生物医药生产商迅速应对当地医疗需求，将能够挽救生命的药品推向市场。KUBio采用集成模块技术，其所有核心厂房的建设，装修，设备，均在德国建设完毕，然后运抵光谷生物城现场进行安装。
    JHL的cGMP标准生产车间将通过美国及欧盟认证，生产工艺将达到国际领先水准，成为一家可以为全球生物制药合作伙伴提供完整解决方案的供应商。