小分子QC检测组经理-高级经理
岗位描述：
1Job Description:
1、管理理化及特殊检测团队的日常活动，包括抽样测试，新方法的转移/接收和验证，以及分析方法的准备和更新。
Management the daily
operation in Physical & Chemical and Special Testing team, including the
sampling testing, the transferring/receiving and validation of new methods, and
the preparation and update of analytical methods.
2、新建及优化理化及特殊检测团队内质量控制体系文件，确保各个方面都符合内部要求。
Establishment and
optimization the quality control system documents within the Physical & Chemical
and Special Testing team, ensuring that all aspects comply with internal
requirements.
3、负责理化及特殊检测检测过程中产生的调查及CAPA提供支持和技术指导。
Responsible for providing
support and technical guidance for the investigation and CAPA arising from the Physical
& Chemical and Special Testing inspection process.
4、负责理化及特殊检测团队人员的培训、评估和管理。指导、发展和支持他们充分发挥潜力。
Responsible for the training,
evaluation and management of the Physical & Chemical and Special Testing
team. Coaching, developing and supporting them in reaching their full
potential.
5、配合QC小分子团队交付计划和持续改进。
Cooperate the delivery plan
and continuous improvement in QC small molecule team.
6、配合部门和客户的GMP相关审核。回复审计报告并创建 CAPA。
Cooperate the GMP audit from
regulatory authorities and clients. Reply to audit reports and create CAPAs.
7、负责理化及特殊检测团队交付情况的定期分析，并制定CAPA，提升团队整体交付能力。
Responsible for the regular
analysis of the Physical & Chemical and Special Testing team's delivery
status, and developing CAPA to enhance the overall delivery capability of the
team.
8、完成领导安排的其他工作。
Completing other interim work
assigned by leadership.
任职要求：
Job Requirements:
1、本科及以上学历，化学、生物化学、生物学、药学、生物工程或相关领域。
Bachelor degree or above,
Chemistry, Biochemistry, Biology, Pharmaceutical, Biological Engineering or
related field.
2、至少8年以上制药行业相关工作经验，其中包括3年的团队管理经验。
With NLT 8 years in
pharmaceutical industry including NLT 3 years team management experience
3、了解小分子药物分析技术，熟悉小分子生产和质量体系。
Knowledge of small molecule
pharmaceutical analysis technology, familiar with small molecule production and
quality system.
4、对药物开发过程的整体观点有很好的理解。
A good understanding of the
overall view of drug development process.
5、对cGMP合规的原则和管理有深入的了解，有强烈的质量意识。
A thorough understanding of
the principles and management of cGMP compliance, and strong quality minds.
6、实验室供应管理技能、EHS知识、5S和精益意识。
Lab supply management skills,
EHS knowledge, 5S and lean sense.
7、使用EXECL等办公软件分析数据。
Using office software such as
EXCEL to analyze data.
8、拥有较好的英语听、说、读、写能力。
Perfect for good English
listening, speaking, reading and writing skills.