400-885-9898
职位描述
QA
Summary of Responsibilities:
•Manages CAPAs to resolution.
•Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager.
•Oversees timely completion of CAPAs and QIs in QMS.
•Supports internal and external teams in creation of CAPAs.
•Maintains good working knowledge of GCP and knowledge of regulatory authority requirements and inspection support.
•Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
•Supports QA lead Sr. Manager and above in pulling metric data, trending, and tracking of QIs for client metrics.
•Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
•Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
•And all other duties as needed or assigned
•Manages CAPAs to resolution.
•Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager.
•Oversees timely completion of CAPAs and QIs in QMS.
•Supports internal and external teams in creation of CAPAs.
•Maintains good working knowledge of GCP and knowledge of regulatory authority requirements and inspection support.
•Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
•Supports QA lead Sr. Manager and above in pulling metric data, trending, and tracking of QIs for client metrics.
•Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
•Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
•And all other duties as needed or assigned
Qualifications (Minimum Required):
•A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience)
•Experience may be substituted for education.
•Fortrea may consider relevant and equivalent experience in lieu of educational requirements
•A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience)
•Experience may be substituted for education.
•Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
•5 years in regulatory environment (experience in GXP roles)
•Strong understanding of QMS and CAPA processes.
•Ability to manage client responsibilities.
•Report and communicates key quality information to Sr. Managers and QA
•Able to work effectively within a team environment.
•Able to communicate effectively during client meetings.
•Knowledge of GCPs/GxPs.
•5 years in regulatory environment (experience in GXP roles)
•Strong understanding of QMS and CAPA processes.
•Ability to manage client responsibilities.
•Report and communicates key quality information to Sr. Managers and QA
•Able to work effectively within a team environment.
•Able to communicate effectively during client meetings.
•Knowledge of GCPs/GxPs.
Physical Demands / Work Environment:
•Some overtime and weekend work may be required.
•Travel Requirement: Yes.
•Some overtime and weekend work may be required.
•Travel Requirement: Yes.
工作地点
北京朝阳区恒通国际商务园
认证资质
营业执照信息
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职位发布者
韩女士/人才招募战略合伙人
刚刚活跃立即沟通
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