Sanofi
pharmaceutical
Assembling&PackagingPCUSpecialist
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“Assembling & Packaging PCU Specialist at Sanofi. Skills: Manufacturing/Packaging management experience, GMP knowledge, leadership and management. Optimize the production process, improve the equipment and system, consistently supply high quality production. Sustainably improve OEE and yield of assembling, packaging equipment and ensure the stable supply to the market”
What You'll Achieve.
consistently supply high quality production; ensure the stable supply to the market; ensure all production activities comply with drug master file, SOPs and GMP requirements; implement production plan strictly and ensure right Plant Service Level and Bias; continuously improve in 5S/HSE aspects and waste minimization; continuously reduce the rate of energy consumption in product value
Industry & Context.
N/A for remote working and travel
What They're Looking For.
Must Have
above 2 years’ Manufacturing/Packaging management experience in pharmaceutical or closely related industry, Basic knowledge of GMP is required, Bachelor’s degree or above in Pharmaceutical Chemistry, Biology or related major, Good command of English both spoken and written
Nice to Have
Certain experience of drug manufacturing & packaging is preferred
What You'll Do.
Optimize the production process
improve the equipment and system
consistently supply high quality production
Sustainably improve OEE and yield of assembling
packaging equipment and ensure the stable supply to the market
Management of the production environment
facilities to make sure all production activities comply with drug master file
SOPs and GMP requirements
To review the batch packaging records and pass to Quality in time
To implement the equipment qualification
process validation and test according to the master plan
To execute and follow the required initial and continuous trainings of production operators
Revise or draft necessary production files
e. g. SOPs production instruction
and ensure the implementation and improvement
Implement SMS standards and continuously improve in 5S/HSE aspects and waste minimization
Implementation of HSE management target plan of this department
implement HSE rules and regulations
HSE operation procedures and HSE technical action plan
Good awareness of energy conservation is required
participate in energy saving actions
and assist in the continuous development of the energy management system
How You'll Work.
Team & Collaboration
assist manager to coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse etc; Support and coordinate with other departments to ensure production activities
Communication Scope
Excellent interpersonal and communication skills; Good command of English both spoken and written
Process & Methodology
Coordinate/join/support variant level projects of Sanofi (Beijing) Pharmaceutical Co. , Ltd.
Full Job Description
**Job Information职位信息** Job title 职位名称: Assembling & Packaging PCU Specialist 组包装PCU专员 • Location工作地点： Beijing 北京 • % Remote working and % of travel expected 远程办公和出差的概率：N/A • Job type工作类型: Full time全职 • Site/Unit 区域/事业部：Manufacturing & Supply制造与供应事业部 **About the job工作职责** Our Team我们的团队： Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients. Device department plays a critical role in ensuring that Sanofi's manufacturing sites produce safe, effective, and high-quality insulin pen products that meet all regulatory requirements and patient needs. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients while continuously improving and operational excellence. 制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。 组包装部在确保赛诺菲生产基地生产安全、有效和高质量的胰岛素笔方面发挥着至关重要的作用，这些产品需满足所有法规要求和患者需求。致力于用优异的战略和工具制造优质的药品并传递到患者手中，并同时持续改进和卓越运营。 **Main responsibilities职责描述 ：** Main Accountabilities 主要职责 • Optimize the production process, improve the equipment and system, consistently supply high quality production. 优化生产工艺，改进设备和系统，保证始终如一地生产出合格产品。 • Sustainably improve OEE and yield of assembling, packaging equipment and ensure the stable supply to the market. 持续提高组装、包装设备的OEE和收率，保证市场稳定供应。 • Management of the production environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements. 生产环境、工艺、卫生、设施等的管理，确保生产活动符合工艺规程、SOP和GMP要求。 • To review the batch packaging records and pass to Quality in time. 审核批包装记录，及时送交质量部门。 • To implement the equipment qualification, process validation and test according to the master plan. 按照计划完成区域内的设备的确认，工艺验证和测试。 • To execute and follow the required initial and continuous trainings of production operato
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