Associate Manager, Quality Control

Job Description

岗位概述

负责兽用疫苗产品在生产过程和放行前的质量检验与实验室管理确保检验结果准确合规并符合公司及监管机构的质量标准作为QC团队的核心执行者需协同生产研发等部门推动检验方法的优化与实验室持续改进

主要职责

• 协助QC经理建立和完善质量控制制度检测流程推动质量体系持续改进

• 主导中国兽药典检测方法兽药GMP等法规要求的落地执行

• 监督并参与病毒含量外源病毒细胞库建立菌毒种扩繁等工作

• 协助QC经理审核检测记录分析报告分析方法验证设备验证等放行文件

• 分析检验趋势数据提出质量改进建议参与实验室流程优化与成本控制项目

• 组织和跟进偏差CAPA纠正与预防措施变更控制推动根本原因分析并实施改进措施

• 配合GMP等监管检查与客户审计准备审计资料并组织回复

• 与研发生产及公司其他工厂保持沟通参与方法验证方法转移稳定性试验及质量问题解决

任职要求

• 学历专业本科及以上学历微生物学生物制药药学兽医生物技术等相关专业

• 工作经验5年以上动物生物疫苗行业QC工作经验具备生物疫苗批检验稳定性研究及方法学验证经验者优先

• 专业能力熟悉中国兽药典检测方法兽药GMP等相关法规与标准熟悉细胞培养病毒培养等生物学方法及质控技术能独立解决复杂的质量问题

• 核心素养具备较强的问题解决能力数据分析能力和项目推进能力能独立开展组织协调与跨部门沟通能力数据敏感度高逻辑严谨责任心强能承受一定工作压力英语流利者优先

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Position Summary:

Responsible for quality testing and laboratory management of veterinary vaccine products during production and prior to release ensuring test results are accurate compliant and meet company and regulatory quality standards. As a core executor within the QC team collaborate with Production R&D and other departments to drive optimization of testing methods and continuous improvement of laboratory operations.

Key Responsibilities:

• Assist the QC Manager in developing and improving quality control policies and testing workflows and drive continuous improvement of the quality system;

• Lead implementation of China Veterinary Pharmacopoeia testing methods and the requirements of Veterinary GMP and related regulations;

• Oversee and participate in work related to virus quantification adventitious virus testing cell bank establishment and expansion of seed strains/viral stocks;

• Assist the QC Manager in reviewing test records analytical reports method validation studies equipment qualification and other release documentation;

• Analyze testing trend data propose quality improvement suggestions and participate in laboratory workflow optimization and cost-control projects;

• Organize and follow up on deviations CAPA (corrective and preventive actions) and change control; drive root cause analysis and implement corrective/improvement measures;

• Support GMP regulatory inspections and customer audits; prepare audit documentation and coordinate responses;

• Maintain communication with R&D Production and other company plants; participate in method validation method transfer stability studies and quality issue resolution.

Qualifications:

• Education & Major: Bachelors degree or above in Microbiology Biopharmaceuticals Pharmacy Veterinary Medicine Biotechnology or related disciplines.

• Experience: Minimum 5 years of QC experience in the animal biological vaccine industry; candidates with experience in vaccine batch testing stability studies and method validation are preferred.

• Technical Competencies: Familiar with China Veterinary Pharmacopoeia testing methods and Veterinary GMP regulations and standards; experienced in cell culture virus culture and other biological methods and QC techniques; capable of independently resolving complex quality issues.

• Core Attributes: Strong problem-solving data analysis and project management skills; able to independently organize coordinate and communicate across departments; high data sensitivity logical and detail-oriented strong sense of responsibility and ability to work under pressure; fluency in English is a plus.

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