北京招聘

Responsibilities:

Data Integrity (DI)

· Establish lifecycle management of DI for GxP process

o Security management

o Backup, restore and archive management

o Business continuity management

o Computerized system validation (CSV) management

o Periodic review of computerized system management

o Audit trail management

o Configuration management

o Data migration management

o Computerized system supplier management

o Computerized system retirement management

· Ensure all the GxP processes/activities meet the requirements of regulations (U.S. FDA 21 CFR Part 11, EU GMP Annex 11, NMPA), guidance and the best practice of industry.

· Perform quality oversight on process/system of GxP area regarding DI.

· Create and maintain computerized system inventory.

· Perform internal DI audit and resolve any DI problem with the other functions.

· Review SOP/Instruction from business department regarding DI.

· Provide DI requirements and training for people who are involved in GxP activities.

· Provide quality oversight for computerized system supplier and CSV supplier.

Especially for Computerized System Validation (CSV) management:

· As Validation Owner to lead the entire process of CSV.

· Support Process Owner to develop User Requirement Specification (URS).

· Create or assist to develop Design/Function/Configuration Specification.

· Perform or assist to perform DQ/IQ/OQ/PQ of CSV.

· Maintain validated state of GxP computerized system.

· Review or approve CSV documents provided by CSV service provider.

· Contact computerized system supplier and sign the Service Level Agreement (SLA).

· Ensure all the CSV activities are consistent in GxP areas.

Internal and External Relationships.

· Interact with people from all levels in HBM relevant functions.

· Interact with regulatory agencies, stay abreast of evolving regulations and influence future regualtions.

Requirements

Education:

· B.Sc. in computer science, automation, biotechnoloy, pharmacology and related major.

· M.Sc. in computer science, automation, biotechnoloy, pharmacology or comparable educational background, highly desireable, but not essential.

Experience & Knowledge:

· At least 5-year working experience in R&D, pharmaceutical or medical device industries, including auditing/inspecting against regulatory standards and/or work in computerized system supplier or computerized system service supplier.

· Extensive and direct 5-year experience related to computerized system validation, including ERP/MES/LIMS/DMS/TMS/QMS.

· Database, computer networking, SaaS/PaaS/IaaS, SDLC experience and knowledge.

· Good understanding of regulation and guidance, including U.S. FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP5.

Core competencies:

· Good interpersonal skills, including but not limited to leadership, assertiveness, negotiation in difficult situations, handling multi-tasks are essential.

· A broad understanding of the IT technology, pharmaceautical industry and GxP regulations.

· Strong process improvement, audit, problem-solving skills.

· Ownership and “I Can Do” attitude.

· English language skill is mandatory. Awareness of cultural difference would be beneficial in promoting and facilitating good working relationships.

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.