- *确保无菌保证项目符合法规部门要求,满足礼来全球质量标准。
- 关注药典、法规有关无菌保障方面的内容,为药物注册提供支持。
- *在工厂的综合无菌保证团队中担当质量代表,例如熟知生产无菌注射剂产品相应的科学原理,包括设备、无菌工艺和容器密闭系统之间的相互作用,以支持综合复杂事件和问题的解决。
- *完成质量部门相关的内外部审计等任务,包括对发现项回复及响应行动进行支持和提出建议。
- *保持开放的沟通环境,加强团队合作,鼓励跨部门的员工合作和沟通;做为secondary loop QA积极构建良好密切的工作关系,培训现场QA无菌相关的知识,确保他们做出有合乎逻辑的评估和正确的决定。
- 做为礼来苏州工厂无菌保证质量代表加强及维护礼来全球关系网,构建与国内无菌制造药企的关系网。
- 通过积极参与安全相关的活动来促进安全状况的改善。
- *审核或者批准TS/MS无菌保证组/验证组负责的策略文件,操作规程,方案和报告,验证总计划等相关文件。
- *审核或批准无菌保证相关的变更、偏差或不一致事件,在评估和调查过程中做为质量监管角色,确保变更实施合规有效,偏差调查彻底且纠正预防措施切实有效。
- *熟练运用质量风险管理方法,评估现有的无菌注射剂产品的生产工艺及对潜在的微生物,内毒素和颗粒物的污染的控制。定期回顾无菌注射剂生产工艺污染控制策略,确保其有效性。
- *与TSMS SA/Validation 合作,对无菌保证/验证项目和改进计划进行质量监督,如对APS,过滤验证,EMPQ,消毒,灭菌,去热原,防渗漏管控,手套管控,更衣管理,颗粒物表征,清洁验证(微生物方面),消毒剂验证和容器密闭性验证进行质量监管。
- *在日常生产活动中作为质量无菌保证业务专家参与工厂无菌检查及审核和批准高风险非编码的干预活动,以及相关控制,并从风险角度评估其可接受性。
- 生物学、微生物学、药学或相关专业本科以上学历(或同等工作经验)
- 理解GMPs及国内适用的标准。
- 有星期一到星期五每天工作八小时的能力
- 可能会被要求加班。
- 有可能出差
- 遵守HSE程序,如发现有不合适之处,及时与HSE沟通
- 及时汇报身边的不安全行为和不安全状态
- 技术写作和演讲技巧。
- 良好的书面和口头英语沟通能力。
- 良好的团队合作能力和人际交往能力。
- 良好的计算机技能。
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Associate-Sterility Assurance QA - Suzhou, 中国 - Lilly
描述
We're looking for people who are determined to make life better for people around the world.
该岗位是负责无菌保证组和环境监测组的区域质量保证人员,负责确保无菌保证项目符合法规要求。
This role is the area QA for TS/MS Sterility Assurance and Environmental Monitoring group, responsible for ensuring the sterility assurance program in Suzhou Parenteral Manufacturing site is compliance with regulatory requirements.
主要职能
Key Objectives/Deliverables
Ensure Sterility Assurance programs meet agency guidelines and Lilly global quality standard requirement.
Review Pharmacopeia updates and Regulatory Documents for submission for the portions related to Sterility Assurance supports.
Serve as quality representative on the site's integrated sterility assurance team, for example, understand very well the scientific principles required for manufacturing parenteral drug products, including the interactions between equipment, aseptic processes and container closure systems, to support the resolution of integrated complicated events and issues.
Complete other tasks related to Quality, such as internal/external audit, including support inspection response and sharing of recommendations.
Maintain open communications and promote teamwork and employee participation and communicate in the work group with other departments; Actively build good and close working relationship as second loop QA, influence and coaching zero & primary loop QA, Coaching shopfloor QA for sterility assurance related knowledge, make sure them do logic evaluation and right decision making.
Strengthen and maintain the sterility assurance network with Lilly Global and build network with local parental pharmaceutical company in China as site sterility assurance QA.
Actively participate in safety-related activities to drive ongoing safety improvement.
Review or approve TSMS-Sterility Assurance/ Validation owned strategy document, procedures, protocols, and summary reports, VMPs and other related documents.
Review or approve investigation of sterility assurance related changes and events or non-conformances, ensure changes are implemented in complaint and effective, deviation investigation thoroughly and CAPA are effective from SA QA perspective.
Well use of quality risk management approaches to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Periodic review contamination control strategy of parenteral products manufacturing processes, to ensure the effectiveness control.
Partner with TSMS SA /Validation and provide quality oversight of sterility assurance/validation projects and improves initiatives, such as provide quality oversight for APS, Filtration Validation, EMPQ, Sanitization, Sterilization, Depyrogenation, Leaks Mngt, Glove Mngt, Gowning, Particle characterization, cleaning validation (microbiological aspects), validation of sanitizing agents and Container Closure Validation.
Participate site aseptic check, review and approve high-risk non-coded interventions and associated controls and use of risk-based approaches to evaluate their acceptability during routine production activities as quality sterility assurance SME.
基本要求
Basic Requirements:
Bachelor degree or above in biology, microbiology, pharmaceutical science equivalent science discipline (or equivalent work experience)
Understanding of GMPs and applicable internal standards
Ability to work 8 hours days- Monday through Friday
Overtime may be required
Minimal travel required
Follow all HSE procedures, immediately highlight when not applicable or not updated
Highlight all at risk conditions and behavior found
Additional Skills/Preferences:
Technical writing and presentation skills.
Good and strong written and oral English communication skills.
Good teamwork and interpersonal skills.
Good computer skills.
其他信息
Additional Information:
申请人将在无菌生产的各个区域工作。有一些潜在的过敏原存在。
Applicant will work in various areas within the Parenteral Site. Some Allergens are present.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
