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Ensures that the commissioning and qualification of the commercial manufacturing facility comply with appropriate regulatory requirement and construction code;
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Lead the C&Q project implementation;
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Coordinate all parties in C&Q execution;
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Support validation related audit/visit by clients and regulatory authorities;
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
SEM-高级验证工程师
SEM-高级验证工程师
中国 无锡
工作职责：
任职能力：
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教育程度/经验Education background/ Experience
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Bachelor degree or Above
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特别知识Special knowledge
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Familiar with regulatory requirements and industry standards, such as 21 CFR Part 210/211/11, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10; ISPE baseline guides, and PDA TRs in cleaning and process.
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技能Skills
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Be experienced in validation and qualification activities and system lifecycle form requirements analysis or product development to commercialization manufacturing, covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes.
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其他要求（比如工作时间等）Other requirements
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At least 8 years of working experience in validation