岗位职责:
1.负责对QC进行日常监督检查,对取样过程、检测过程、记录填写、实验室数据完整性等进行监督检查,对现场发现的问题进行落实和跟踪,直至完成。
Be responsible for supervising and inspecting the QC department. Conduct inspections on the sampling process, testing process, record filling, and the integrity of laboratory data. Address and follow up on any problems identified on-site until they are resolved.
2.物料和产品放行监控:复核检验报告书、检查成品检验报告和原始记录是否相符,协助领导完成放行。
Material and product release monitoring: Review the consistency between the inspection reports, the final product inspection reports, and the original records; assist the supervisor in completing the release process.
3.QC OOS对接、审核和跟踪。
QC OOS interface, review and tracking.
4.质量文件的管理:根据国家药监部门及公司管理制度的要求,参与文件评审和操作规程和记录的修订,并进行技术复核。
Management of Quality Documents: In accordance with the requirements of the national drug regulatory authorities and the company
s management system, participate in document reviews and the revision of operation procedures, and records, and conduct technical reviews.
5.商业化产品在官方机构检测的对接及问题协调解决。
Commercial products undergo testing and coordination for interface issues by official institutions.
6.质量管理涉及的其他工作的协助和支持,如生产的现场监督、批生产记录的审核、供应商管理等。
Other tasks related to quality management that require assistance and support include on-site supervision of production, review of batch production records, and management of suppliers, etc.
7.质量保证相关文件的起草,审核和修订。
Drafting, reviewing and revising the documents related to quality assurance.
8.领导安排的其他工作。
Other work assigned by the leader.
任职要求:
1.本科以上学历,药学,化学,微生物学,生物学,或相关专业。
Bachelor or above degree in Pharmaceutical, Chemical, Microbiological,Biological or related field
2.3年以上外资或合资生物大分子企业相关工作经验,至少2年抗体活性检测经验。
At least 3 years of relevant working experience in foreign-funded or joint venture biopolymer enterprises, with at least 2 years of experience in antibody activity testing.
3.良好的团队合作精神,以及较强的沟通协调能力。较强的人际交流能力,特别是在有不同意见的时候,能够与不同部门,尤其是官方检测机构建立合作关系。
Good teamwork spirit and strong communication and coordination skills. Strong interpersonal communication ability, especially when there are different opinions, the ability to establish cooperative relationships with different departments, especially official testing institutions.
4.较强的处理,调查以及解决问题能力。
Strongly address, investigate and solve ability
5.良好的英语读写能力。
Good English reading and writing skills.