QC Associate Director

Brief Job Description 工作描述简述

• As technical consultant in maintain / improve GMP compliance in daily Analytical Lab operation.

维护/改进分析实验室日常运作中的GMP符合性

• Be responsible for team and personnel capability development

发展团队及人员专业技术能力

• Lead the initiatives for quality control procedure or management continuous improvement

组织和领导质量控制流程和管理的持续改进项目

• Contribute to the QA function in developing / improving quality management system

协助整个质量部改进质量管理体系

Typical Accountabilities 主要职责 Management of Analytical Lab affairs 分析实验室日常事务管理

• As technical consultant in maintain / improve GMP compliance in daily Analytical Lab operation.

作为技术顾问以维护和改进分析实验室日常运作中的GMP符合性

• Has a direct involvement in regulatory inspections

直接参与内外部法规审计

• As technical consultant in analytical technology transfer

技术支持 QC实验方法的转移

• Provides analytical expert knowledge and support to the complex troubleshooting issues, novel situations and oversees the delivery of training and coaching

提供化学分析专业知识和建议，支持复杂问题的解决并确保技术培训的实施

• Technical problem solving

技术问题的解决

Continuous Quality Improvement 持续质量改善

• As technical consultant in maintain / Improve analytical lab procedure, secure

operation GMP compliance

维护/改进分析实验室流程，确保高度的 GMP符合性

• Lead the initiatives for quality control procedure or management continuous

improvement

组织和领导质量控制流程和管理的持续改进项目

SHE 安全环境健康 - Identify and understand the SHE risk factors within the department.

识别和了解本部门的安全危险因素

• Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.

制定和执行 SHE方案以强调在相应区域的关键 SHE事件并确保跟进措施的落实执行。

Qualifications资质 Education, Experience and Training 教育、工作经验和培训

• Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.

大学本科以上学历，药学、化学分析或相关专业毕业

• 5+ years prior experience in GXP environment of pharmaceutical industry

制药行业 5年以上工作经历

• 5+ years prior experience in quality control - analytical

具有至少 5年从事药品分析检验工作

• Knowledge and a comprehensive understanding of the principles and concepts of compliance management and Good Manufacturing

Practice/Good Laboratory Practice

对法规符合性管理的要求和概念、GMP/GLP具有丰富知识和深入的理解

• Experience of analytical method transfer or validation.

分析方法转移或验证经验

• Overall quality management system and GMP knowledge

具有全面地质量管理体系和 GMP知识

• Capability of providing direction to the analytical lab including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.

能够为分析实验室在仪器管理、方法学问题、非常规的分析测试以及新技术的评估和应用方面提供指导

• Good collaboration, team coaching and people development capability

良好的合作、团队建设和人员发展能力

• Good command of English

良好的英文能力