苏州招聘

Position Brand Description:

TS/MS Sterility Assurance Specialist/Officer is responsible to provide leadership and support in sterility assurance for all parenteral operations and aseptic control of manufacturing facilities. This TS/MS Sterility Assurance Specialist/Officer will partner with the QA Sterility Assurance Microbiologist in development, qualification/validation and implementation of equipment, process, procedures and training related to sterility assurances including cleaning, sterilization, filtration, media fills and environmental monitoring. He/she will be expected to partner with SMEs at corporate/other sites in sterility assurance and to continue to develop a higher level of expertise in aseptic manufacturing and sterility assurance within TS/MS organization.

- Understand scientific principles required for manufacturing parenteral drug products, including interactions between chemistry, equipment, aseptic processes and container closure systems.
- Develop, qualify/validate and implement sterility-assurance related processes, batch records and procedures, PFD and control strategies with science-based and risk-based approach.
- Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Understand, justify and document sterility-assurance related validation activities including cleaning validation and sterility assurance with data-based, science-based and risk-based approach to evaluate the capability of sterility assurance processes to meet its stated purpose.
- Prepare, review, approve relevant documents and provide technical support to sterility assurance including regulatory submissions, change controls, deviation investigations, validation protocols and summary reports, batch records, SOPs, PFDs, VMPs, and APRs.
- Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver business and quality objectives. Maintain open communications and promote teamwork and employee participation in the work group.
- Support and/or lead technical projects (experimental, modeling and/or production data analysis) to continually improve sterility assurance level, aseptic operations and product quality.
- Adherence to all the safety policies, standards and guideline and be responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.


Basic Requirements:

- BS or MS degrees in microbiology or related science or engineering discipline.
- 0 - 5+ years GMP experience, preferably related to parenteral manufacturing and/or sterility assurance.
- Some or in-depth understanding of microbiology principles and related sterility assurance including its relationship and interactions with process and equipment.
- Good skills in analytical thinking, multi-tasking, decision-making and problem-solving.
- Good skills in leadership and project management with ability to influence across multiple levels of organization and with strong interpersonal skills.
- Demonstrated ability to work independently and a good team-player.
- Some or in-depth understanding of compliance requirements and regulatory expectations.
- Technical and scientific knowledge with good computer skills.

美国礼来制药（eli lilly and company）是一家全球性的以研发为基础的医药公司，创立于1876年，总部位于美国印地安那州印第安纳波利斯市，业务遍及全球 125 个国家和地区。礼来致力于为全人类提供以药物为基础的创新医疗保健方案，使人们生活得更长久、更健康、更有活力。

礼来制药与中国的渊源可以追溯到二十世纪初页。礼来于1918年来到中国，并将其***个海外代表处设在上海，从而迈出了全球化的***步。几经风雨历练，礼来于1993年重返中国。二十年多来，礼来本着“植根中国，造福中国”的理念，着力拓展在华业务，目前已经形成从研发、生产到商业运营的全产业链格局。礼来中国如今已成长为礼来全球第二大分支机构。

礼来在苏州建立有礼来苏州制药有限公司，在上海张江高科技园区建有礼来中国研发中心，并在全国数十个城市建立了办事机构，在中国拥有员工四千余人，目前公司业务已经深入到中国近四百个城市，礼来连续十余年在中国保持两位数的增速。

礼来在中国的许多医药领域居领先地位，如抗生素、中枢神经、肿瘤、内分泌等。礼来的品牌希刻劳、稳可信、百优解、再普乐、欣百达、健择、力比泰、易维特、复泰奥、希爱力、人工胰岛素优泌林及其***伴侣优伴，人胰岛素类似物优泌乐、欧唐宁等已被公认为创新的药物。它们挽救了病人生命、提高了大众的生活品质，同时为患者、医务工作者和医疗保障体系提供了更有价值的治疗选择, 降低了治疗成本。

礼来在中国的经营原则与我们在全球的原则完全一致，充分体现了“诚信至上,追求卓越,以人为本”的信条。礼来的宗旨是成为一名诚信的中国企业公民，通过“植根中国，造福中国”，尽全力为中国人民提供最新和***质量的药品，挽救病人的生命，提高大众的生活品质。

礼来致力于成为中国医疗保健领域的主要战略伙伴，高瞻远瞩，长期回报社会。重返中国二十多年来，礼来为发展公共卫生事业、社会救助活动投入了巨大的热忱。同时，礼来通过开展形式各异的大众教育活动，传递疾病信息，普及健康知识，提高大众的生活品质。由于我们在公益事业方面的突出表现，礼来相继荣获了“光明公益奖”、“世界500强企业慈善公益榜”、中国制药企业社会责任“孺子牛奖”、“中国企业社会责任特别大奖”、及卫生部授予的“特别贡献奖”等多个奖项。

礼来中国的员工价值主张是“享你未来”！具体到整体回报的四个方面，礼来中国分别倡导业享所得、家享关怀、才享卓越、心享悦然。

薪酬方面我们倡导业享所得。每一份努力，都让梦想离得更近。承担的职责越多，绩效越优秀，获得的薪酬回报也越高。

福利方面我们倡导家享关怀。每一程出发，都有关爱悉心相伴。我们希望关怀员工每个人生阶段不同的需求并提供支持，让每位员工都能享受美满无忧的人生。

个人发展方面我们倡导才享卓越。每一步成长，都有平台助力腾飞。我们致力于为每位员工提供全面的职业发展支持，助你成为令人艳羡的业界精英。

工作环境方面我们倡导心享悦然。每一次成功，都因身心自在其中。礼来不只是一家公司，它更像一个大家庭。我们希望每天都和志同道合的像家人一样的同事们一起奋斗，一起去取得成功，并一起分享成功的喜悦。

如果你一直想加入这家有着良好声誉的公司， 现在， 机会之门正在敞开！我们寻求优秀的你， 自信的你加入我们， 和礼来一起共同成长。无论你是经验丰富的专业人士， 还是胸怀壮志的应届毕业生，相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧，加入我们， 礼来将助你成就梦想！

详细信息请查阅礼来中国招聘官方网站http://www.lillychina.com/careers