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Specialist, Quality System     

龙沙生物技术有限公司 | 外商独资 | 200--500人 | 制药/生物工程

¥8000~12000元

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免费班车 带薪年假 定期体检 年终双薪 五险一金 周末双休
Specialist, Quality System    

龙沙生物技术有限公司 | 外商独资 | 200--500人 | 制药/生物工程

该公司所有职位
免费班车 带薪年假 定期体检 年终双薪 五险一金 周末双休
职位类别:药品注册/生产/质量管理
工作性质:全职
最低学历要求:本科
年龄要求: 不限
工作年限:不限
婚姻要求:不限
工作地区:黄埔区
户籍要求:不限
目前住地:不限

¥8000~12000元

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职位信息
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
公司简介
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
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  
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  
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  
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  
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