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advance_sh铜虫 (小有名气)
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[交流]
外资兽药公司招聘技术生产专员-上海 已有1人参与
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帮一家美资的兽药公司招聘技术生产专员，负责指导解决外包工厂大规模生产中出现的各类问题。工作地点：上海。 Key Objectives/Deliverables: • Provide process instructions and technical support and leadership to contract manufacturers. • Work with individuals in process development and manufacturing components to implement new processes in manufacturing. o Participate in tech transfer activities. 1. Equipment Cleaning Validation 2. Process and Packaging Validation 3. Production and Packaging Master Batch Record Creation 4. Process Flow Document Creation 5. Development Design of Experiments for fit to plant operations o Identify manufacturing critical process parameters from lab experimentation and/or manufacturing experience. • Author Annual Product Reviews (APRs) o Review APRs from the contract manufacturer and write APR to fill indentified gaps to the respective GQS. • Support incident/deviation/investigations (i.e., from stability, from APRs, from storage) o Review deviations prepared by the contract manufacturer for the potential impact to SISPQ o Work with cross functional groups for timely resolution and closure of site specific deviations • Conduct/Provide technical support for manufacturing process validation o Review/write process validation protocols. Minimum Requirements: • Large scale classical fermentation experience and/or • Purification experience specifically: centrifugation, filtration, spray drying, fluidized bed drying, chromatography, tangential flow filtration, ceramic microfiltration. • Finishing experience specifically blending and bagging operation for animal health premixes. • Strong problem solving capabilities including strategic and creative thinking • Strong interpersonal/communication skills: verbal and written • Fluent in English and Chinese (Speak, Read & Write) • Cross-functional networking and influencing ability • Ability to handle multiple priorities and deal with ambiguity • Computer literacy (Excel, Word and PowerPoint) • Strong understanding of manufacturing equipment, materials, and technologies utilized in fermentation, purification and finishing operations. • Understanding of global cGMPs for API manufacturing and drug products. • Must understand the manufacturing stability requirements for international shipments. • Basic project management skills. • Understanding of analytical methods such as HPLC. • Trained in Root Cause Analysis • API and Drug Product Packaging Experience • Advanced Science degree (e.g. Chemistry, Engineering, Biochemistry, Industrial Microbiologist) or Bachelors of Science degree with equivalent work experience. 有意者请联系aelanzhang@gmail.com 有疑问也请发邮件，谢谢 |
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advance_sh
铜虫 (小有名气)
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