龙沙生物技术有限公司-job168网

龙沙生物技术有限公司

外商独资 | 200--500人 | 制药/生物工程

关于龙沙生物制药中国
作为全球生物制品定制生产行业的开拓者和领军者，龙沙生物制药拥有世界领先的专业技术和生物制品全球上市申报和生产的成功经验。依托其全球网络与本地运营的综合能力，秉承“以终为始，始终安心”的宗旨，龙沙生物制药致力于与任何类型、阶段和规模的生物制药公司合作，为生物医药企业提供从临床前开发到上市生产的完整解决方案，立志成为最值得中国客户信赖的CDMO合作伙伴，助力它们娴熟快速、卓有成效地为患者提供生物制药产品，惠及更多患者。
龙沙生物制药为生物医药企业提供从临床前开发到商业化生产的完整解决方案。其业务涉及哺乳动物和微生物的生物制药、生物偶联物等领域。为了满足中国对于世界级CDMO服务日益增长的需求，龙沙生物制药于2018年正式进军中国市场，在广州投资新建了在华首个哺乳动物生物技术生产工厂，并计划从2021年全面投入运营。作为龙沙第九个哺乳动物生物技术生产工厂，广州基地将完全融入龙沙覆盖美洲、欧洲和亚洲的全球生物制造网络。该基地将坚守龙沙全球统一的质量和运营标准，满足中国客户对世界一流CDMO服务不断增长的需求。欲了解更多，请浏览：https://www.lonza.com/。

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联系我们

联系地址：广东省广州市黄埔区九佛建设路1039号

联系人：饶小姐

该公司所有职位

Specialist, Quality System

黄埔区 | 本科 | 不限

8000-12000元

Key responsibilities:• Support the start-up of Quality Systems for the site.• Execute and maintain the Quality Systems at the site.• Document Management System• Write, Revise, Review and Approve Standard Operation Procedure, protocols, reports or records.• Conduct training• Provide guidance on Current Good Manufacture Practices, Good Documentation Practices and Data Integrity requirements.• Training/Learning Management System• Maintenance of training curriculum/tasks.• Custodian and archival of training records.• Provide guidance on Learning Management System usage.• Trackwise System• Provide guidance on deviation management, change control and Corrective And Preventive Actions• Conduct training and provide guidance on trackwise system usage.• Communicate quality systems and compliance requirements effectively to peers and stakeholders.• Provide compliance support to staff in all departments.• Participate in regulatory, customer and internal audits.• Any other tasks as and when assigned by the supervisor/line manager.Key requirements:• Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)• Good knowledge and experience of the practical and theoretical requirement of validation program in Good Manufacture Practices facility• Good leadership skills• Strong interpersonal skills• Effective Communicator (oral and written)• Exhibit good quality decision making traits• Meticulous and Systematic• Analytical Mind• Ability to define specific goals clearly, to develop and prioritize activities• Team player, with strong focus on safety, quality and timelines

申请

Specialist, Validation

黄埔区 | 本科 | 不限

10000-15000元

Key responsibilities:• Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a small scale, multi-product, GMP biotech contract development/manufacturing facility• Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure• Support / participate in validation activities during facility startup / shutdown / changeover and routine GMP operations• Support / participate in Site Validation Maintenance Program and implementation of department training requirements• Develop Validation Plans for a change implementation project as required• Active co-ordination with internal and external validation resources to achieve department / project goals• Liaise with system owners, quality unit and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations• Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure• Participate in Customer / Agency Audits and Inspections as required• Participate in on-job training program for staff• Any other tasks as and when assigned by supervisorKey requirements:• Familiarity with Regulatory requirements and local Codes & Standards (e.g.FDA, EMEA,GAMP and ICHQ7)• Good knowledge and experience of the practical and theoretical requirement of validation• Program in GMP facility• Good leadership skills• Strong interpersonal skills• Effective Communicator (oral and written)• Exhibit good quality decision making traits• Meticulous and Systematic• Analytical Mind• Ability to define specific goals clearly, to develop and prioritize activities• Team player, with strong focus on safety, quality and timelines

申请

Quality Operation Specialist

黄埔区 | 本科 | 不限

8000-12000元

Key responsibilities:• Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a small scale, multi-product, GMP biotech contract development/manufacturing facility through way of working below:o Support / participate in validation activities during facility startup /shutdown / changeover and routine GMP operationso Support / participate in Site Validation Maintenance Program and implementation of department training requirementso Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closureo Issue and update SOP related to validation. Execute gap analysis of globe documents related to validation. Organize and provide the site level technical training related to validation to enhance the competence level at site level.o Active co-ordination with internal and external validation resources to achieve department / project goals. Liaise with system owners, and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectationso Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure.• Participate in Customer / Agency Audits and Inspections as required• For Routine Engineering activity:• Monitor day-to-day routine engineering activities through way of working below:• A competent Reviewer of SOP or records, protocols/reports belong to engineering area, which may including engineering utility system, maintenance activity or automation/ calibration management;• Handling deviation and Corrective and Preventive Actions in Trackwise System (TW); Able to assist in deviation investigations and discrepancy reports;• Able to develop skill as an internal cGMP auditor;• Provide training and technical advice to other staffs as required;• • Identify situation which may require escalation to supervisor;• Any other tasks as and when assigned by managerKey requirements:• Relevant experience and accomplishment to dictate final position for which the candidate may qualify• Good problem solving and analytical skills• Good communication skills• Decision Making• Planning/Organizing• Effective Communication• Personal Orientation• Teamwork

申请

Scientist Analytical/Senior Scientist Analytical

黄埔区 | 本科 | 不限

8000-15000元

Key responsibilities:• To perform hands-on laboratory work with high levels of right first time in the upstream, downstream or analytical development team contributing to the development of processes suitable for technology transfer to the Current Good Manufacture Practices manufacturing teams. An understanding of Current Good Manufacture Practices manufacturing facility constraints and their impact on development activities will be developed.• May contribute to method validation / characterisation activities by performing supporting laboratory scale studies.• Interpret analytical data provided by the analytical team as required to define subsequent steps.• Start to deliver high quality communication to ensure an outstanding customer experience (written reports, teleconferences, face-to-face meetings).• Working as part of a site and/or global project team in multiple projects and ensure timely delivery of project workstages.• Processes include either one of the following: Analytical Test methods include, but are not limited to, techniques using capillary electrophoresis, high-performance liquid chromatography, oligosaccharide analysis, spectrophotometry, enzyme-linked immunosorbent assay, Quantitative real time polymerase chain reaction, etc.• Adherence to Environment; Health; Safety rules and regulations required at all times. Suggests improvements where possible.• Documentation of results in accordance with Lonza policies and current Good Manufacturing Practices – as appropriate.• General laboratory support including housekeeping, equipment calibration and maintenance, inventory of supplies, etc.• Efficiently manage own time to meet commercial goals.• Draft reports suitable for Science Lead review.• Contributes to the design and implementation of operational efficiency projects.• The initial phase of this position will be involved in the establishment of the facility (including but not limited to equipment purchase and qualification runs, facility design and set up)Key requirements:• Degree or Masters in a relevant Science field or Equivalent.• Fresh graduates or with 1 to 2 years work experience.• Understanding of theory and application of recombinant protein expression or protein production, purification or analysis• Understanding of Current Good Manufacture Practices regulations.• Good problem solving, analytical and teamworking skills.• Good communication skills (verbal and written).Fluency in spoken and written English is an advantage

申请

生产操作工

广州 | 高中 | 不限

5500～6499元

生产技术员按照指令和遵循SOP进行生产操作和设备设施维护，确保涉及高活性物料生产计划按时完成，确保生产过程安全、符合GMP要求以及符合公司其它的有关SHE方面的要求。工作职责:• 严格按照指令和标准进行操作，在操作过程中贯彻公司有关于安全、GMP和环保方面的要求； • 在工作过程中积极主动沟通和团队合作，观察和及时汇报各种异常现象； • 按照GMP的要求填写生产记录，并对生产记录的准确和真实性负责； • 严格按照公司的要求进行交接班，负责相关生产区域的卫生清洁； • 在工作过程中对设备的安全负责，并负责配给个人的防护器材的维护； • 有责任提合理化建议，参与工艺和操作的持续改进，按时上交安全观察卡；• 执行领班分派的任务，遵守的公司的安全管理规章制度和员工手册。任职条件:• 中专以上学历，化工、制药或其他相关专业；• 化工或相关行业工作经验一年以上（优秀的应届生也可考虑）；• 有GMP知识或对常用化工设备和单元操作了解的优先；• 有良好的安全、环保意。

申请

物料管理员

南沙区 | 高中 | 不限

5500～6499元

高级生产技师-物料管理员，主要负责生产物料准备和后勤工作，负责生产废物的管理以及EPM车间内的生产辅助设施的运作，负责EPM车间内的消防设施和维护。工作职责:负责各生产线原料领取，劳保用品发放，滤芯滤袋验收，成品移交仓库并盘点数量等内容；管理纯化水、物料仓库、余料仓库、备品备件仓库等公用设施，负责生产过程中产生的三废按照规定及时处理，就废物管理事项对项目提供支持，并和废物处理有关部门保持密切沟通；三废月报统计和审核数据，生产过程中及时转移废水、废液；生产结束后统计能耗和处理剩余物料；按要求对厂房消防设施进行巡检和维护，负责暂存间的日常卫生管理；签发工作证，协调其他部门工作，确保组内人员严格按照GMP要求和公司SOP规定进行操作；落实CNGZ-18178《安全生产责任制》的岗位职责；完成上级分配的其他任务。任职条件:高中以上学历或化学制药或化学工程等专业大专学历优先考虑；熟悉设备原理，化工原理，化学物料和GMP要求；能有效沟通，问题解决，团队合作；持叉车证上岗。

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广州市：12333 越秀区：83364523 海珠区：84480422 荔湾区：81376063 天河区：87568311	白云区：26090299 黄埔区：82295406 番禺区：84645660 花都区：86969113	南沙区：34689078 从化区：87960843 增城区：82755650 开发区：82111294

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