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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.
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