QC Project Engineer
Tianjin, Tianjin MunicipalityOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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Job Description
岗位职责
- 参与新产品项目分析方法的转移，确认和验证，起草相应的研究验证文件，保证方法学验证的科学性、合规性，并审核方案和报告。
- 参与新产品项目的规划，相关活动的统筹和安排，追踪项目进度，确保按时完成项目。
- 参与新产品建立实验室对新产品的检验能力，新的分析技术，深入掌握检验关键点。
- 维护实验室新的分析防管理文件，解决验证工作中的异常情况，熟悉实验室调查流程。
- 参与实验室精益管理，参与实验室持续改进。
- 进行相关Global 文件或本地法规的GAP分析，并完成相关行动。
- 根据实验室不同时期的业务需求，参与并支持其他小组的工作。
- 遵守公司EHS的管理规定，严格执行实验室相关的化学品管理、个人防护用品、危险废弃报废等各项要求。
岗位任职要求
- 本科及以上学历，药学或化学相关专业
- 至少5年制药行业工作经验，其中至少3年质量控制相关经验
- 熟悉和理解法规要求
- 数据分析能力，理解数据，基于数据做质量相关决定的能力
- 调查和分析问题的能力，及解决技术问题的能力
- 风险识别及管理的能力
- 熟悉并能够操作SAP系统(如LIMS，CDS等）
- 熟练的英读写能力,能够用英语进行沟通
Locations
Tianjin, ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
What we believe in
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
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Integrity
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Fairness
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Honesty
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Perseverance
Related Content
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Global Top Employer 2024 Takeda named Global Top Employer for seventh consecutive year. -
Putting Patients First Explore more. -
Our R&D Pipeline Explore more.
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