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Operation Manager, China Small Scale Facility

Plats Wuxi, Jiangsu Sheng, Kina Jobb-id R-088240 Datum inlagd 08/06/2020

Responsibilities:

  • Ensure team are following company culture and maintain healthy team climate

  • Drive team capability uplift and organization effectiveness

  • Drive BPM clinical manufacturing continuous improvement, e.g, set long term BPM strategy, annual maturity review, KPI deliverables, BPM capability and culture uplift

  • Lead technical transfer of new medicines from PTD or Pharm Science to CSSF on time in full

  • Continuously improve TT process

  • Ensure clinical manufacturing and supply deliverables according to the plan and budget

  • Ensure Quality, SHE and Compliance are well embedded across clinical manufacturing operations

  • Ensure the matching rate of production capacity and the asset

  • Author production and technical related SOP, WI, BRP, Technical study, Validation documents, etc., SAP master date maintain

  • Author production and technical training materials and manage product knowledge

  • To coordinate with the site QSR implementation

  • To draft VMP/VP as appropriate

  • To review and approve the validation doc as appropriate

  • Be as the validation representative to facilitate the validation work across the project

  • Be as the validation representative to do the validation assessment for each change control via risk-based approach

  • To generate/maintain the validation training package

  • Work with internal and external stakeholders, e.g., quality, supply chain, E&SHE, PTD, Pharm Science, etc., to manage production/technical related affairs

Requirements:

  • University graduate or above

  • Professionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement

  • GMP/regulatory and Oral Solid Dosage knowledge

  • Professionalism in qualification and validation of process equipment, process and cleaning

  • Professionalism in technical study of OSD

  • Experience in PM and Technical Transfer

  • Experience in production management, incl., planning, manufacturing, maintenance, IT system (SAP, Datahistorian), compliance of GMP/SHE, etc.,

  • People management experience, especial in shop floor staffs management

  • 8+ years of experience in pharmaceutical industry with experience of technical transfer, or quality or production management

  • Good track records in TT and production management

  • Statistical knowledge with experience in DoE, limit setting etc.,

  • Good English in reading, writing, speaking

  • Good MS-office skill

  • Good communication skills, management skills, problem-solving, coaching, work under pressure

工作职责:

  • 确保团队符合公司文化及打造健康的团队氛围

  • 持续提升团队能力和组织绩效

  • 持续提升临床样品生产的业务流程,如业务流程长期策略,年度成熟度评估、绩效交付、能力和文化提升等

  • 推动从PTDPharm Science CSSF的技术转移按照计划交付

  • 持续改善技术转移流程

  • 确保临床样品生产和工艺按计划和预算交付

  • 确保临床样品生产和供应的全过程符合GMPSHE, Compliance的要求

  • 确保生产设备等固定资产配额和产能的评估及管理

  • 撰写生产/技术相关的SOPWI, 批记录、技术文件、验证文件等

  • SAP主数据维护

  • 撰写生产/技术培训材料,并管理产品知识

  • 协调工厂QSR 的实施

  • 起草验证主计划/计划(如适用)

  • 审核和批准验证文件(如适用)

  • 作为验证代表,推进整个项目的验证工作

  • 作为验证代表,对每个变更控制在考虑风险的基础上进行验证评估

  • 制定/维护验证培训材料

  • 和内外部的利益相关者合作,管理生产和技术相关的事务

任职要求:

  • 大学本科以上

  • 专业级的制药知识,包括生产工艺、验证、问题解决、调查和持续改进

  • GMP/法规和口服固体制剂知识

  • 精通设备设施验证、工艺验证和清洁验证

  • 精通固体制剂的技术研究

  • 在技术转移项目上,具备项目管理或技术支持的经验

  • 生产管理经验,比如计划、生产、维修保养、IT系统SAP, Datahistorian),GMP/SHE的符合性,等等

  • 人员管理经验,特别是一线生产员工的管理

  • 8年以上制药行业经验,包括技术转移、或质量管理、或生产管理

  • 理想:在生产和技术转移领域都良好业绩,同时具备统计学知识,具备实验设计、限度设定等统计学应用经验

  • 较好英语读,写,说能力

  • 良好的MS 办公软件应用技能

  • 良好的沟通技能、管理技能、解决问题的能力、辅导能力及能够承受一定的工作压力



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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