济宁招聘

职责描述：
a) Maintain a fit-for-purpose Quality Management System across the ChP, ICH, GxPs in compliance with regulations through management of quality systems and standards. 
b) Effectively interact with internal team and manage all third parties contracted to perform GMP manufacturing activities to ensure full compliance and adherence to timelines. 
c) Perform batch release activities and review reprocessing and rework procedures.
d) Oversee GLP testing to assure conformance with protocols, SOPs, and GLP regulations.
e) Administer a document management system for QA and regulatory submissions. 
f) Ensure the development and maintenance of GxP SOPs, in accordance with current regulation and practices, and ensure personnel training files are maintained.
g) Plan and conduct GxP audits and inspection readiness of laboratories, manufacturing sites and clinical investigations to assess compliance with all pertinent regulations and company requirements (inclusive of comprehensive corrective and preventive action development, approval, and execution).
h) Partner with cross-functional stakeholders for continuous improvement activities, create/revise procedures/practices and specifications, and provide training on quality systems and procedures.
i) Serve as subject matter expert, keeping current with ICH, GxPs and industry practices, in order to provide organizational support.

任职要求： 
a) Master’s degree in a scientific or health-related field, minimum of 8 years of Quality experience in the biotech or pharmaceutical industry
b) Extensive knowledge of ChP, ICH, GxP and QA principles, practices, and standards
c) Experience with NMPA/FDA authority GxP inspections and expectations relating to pharmaceutical quality/CMC
d) Adept at multi-tasking, problem-solving, leading cross-functional teams, and collaborating with third parties

菲鹏生物股份有限公司（以下简称菲鹏生物）成立于2001年，是行业领先的体外诊断技术平台型企业，提供的产品和服务包括体外诊断试剂创新标志物及核心生物活性原材料，同时提供体外诊断开放仪器平台和试剂整体解决方案。
菲鹏生物洞悉医疗行业从“治已病”到“防未病”的前沿趋势变化，搭建了体外诊断全面、完善的技术平台，自主研发推出了包含抗原、抗体、酶等在内的1200+核心工业级原料，广泛应用于免疫诊断、生化诊断、分子诊断和高通量测序等领域，助力疾病的早诊早筛与精准诊断。
同时，基于对行业发展趋势的深入理解，提供开放仪器平台和试剂整体解决方案，服务于全球诊断公司和检测机构。
菲鹏生物期望通过持续创新的产品与服务，以诊断生态的形式与合作伙伴共同推进诊断产业的发展，实现“让诊断更早、更准、更便捷、更便宜”的使命。

公司福利
1. 行业竞争力薪酬，针对不同性质岗位设计相配套的薪酬结构，一般为：基础薪酬+年终绩效薪酬+节假日福利+即时激励等；
2. 弹性工作时间，5 天 7.5 小时；
3. 健全福利保障，六险一金（入职即额外补充团队意外险），年度三甲医院健康体检，员工专属购房贷款；
4. 政府人才补贴，东莞松山湖/深圳：本科1.5w，硕士3w, 博士5w,一次性发放；公司具备资质可提供孔雀计划申请服务，奖金为160W、 200W、300W；
5. 专业的技术培训，一对一导师制培养，双通道晋升渠道；
6. 无忧生活福利，上下班通勤班车免费接送（深圳和东莞地区），花园式人才公寓，自有餐厅，健身房，咖啡厅，深圳1小时生活圈；
7. 假期福利，法定节假日、年假、婚假、产假、丧假、高考陪考假等带薪休假，公司另为员工提供每月半天有薪福利假或病假的福利；
8. 团队活动，年度旅游，篮球/羽毛球/乐队社团，家属开放日/联谊；