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기관 IVI(국제백신연구소)(서울) 
프로그램 (바이오메디컬) IVI(국제백신연구소)(서울) Lab Quality Manager 채용 
마감날짜  

채용시 마감

(바이오메디컬) IVI(국제백신연구소)(서울) Lab Quality Manager 채용

 

Lab Quality Manager

We are seeking a Lab Quality Manager for a 2-year-regular position (renewable) at the International Vaccine Institute.

 

Job Description:

This job is responsible for ensuring that all laboratory research (including activities within both Clinical Research Laboratories and Vaccine Process Development) conducted or supported by IVI comply with the IVI Quality Policy and relevant guidelines and regulations. This will involve overseeing laboratory quality efforts in concert with and support of the overall IVI Quality Management organization, requiring effective and co-operative interaction with IVI staff and external consultants and stakeholders. In addition, this job will be responsible for supporting and maintaining the electronic systems document management for use throughout IVI, ensuring proper configuration to support project work.

Main Roles & Responsibilities

  1. Quality Management system development
  • Support the development/periodic review of lab Quality Management system and relevant documents (including SOPs)
  • Update and maintain documents needed for the Lab Quality, i.e., Quality SOPs that support the Quality Management system
  • Maintain working knowledge of up-to-date applicable guidelines and regulations related to the conduct of research, and the principles and methods related to quality management
  • Report proposed changes to policies & procedures to the IVI Quality Standards Committee for consideration
  1. Quality Assurance/Quality Control
  • Support the development of QA/QC activities plan and other relevant documents for lab departments and each individual project in which IVI assumes a sponsor or collaborator role to ensure all lab research activities are in line with IVI quality policies and relevant guidelines
  • Ensures that data are recorded, analyzed, and recoded in accordance with protocols and relevant standards
  • Ensure proper maintenance of Lab documentation databases and systems in accordance with IVI quality policies and relevant guidelines / standards, e.g., lab notebooks, SOPs, GCLP documents
  • Coordinate internal process audits and external site audits as needed to ensure ongoing compliance with SOPs, study protocol, and regulatory requirements
  • Coordinate periodic SOP review/approval process for lab departments
  • Support team in evaluating potential technical transfer partners regarding technical capabilities, preparedness, quality assurance, and standards prior to initiating tech transfer
  • Support tech transfer process and review processes and final documentation to ensure compliance with IVI quality policies and tech transfer protocols
  1. Quality Improvement
  • Develop and share reports on QA/QC activities, internal/external audit results detailing key observations and Corrective and Preventive actions (CAPA)
  • Implement CAPA plans for any deficiencies identified external to an audit or audit observations identified/communicated by IVI stakeholders, regulatory agencies, donors or collaborators
  • Develop and provide comprehensive Lab Quality Training, i.e., IVI policy / SOP trainings, periodic internal GXP trainings (as required)
  • Conduct user training for system on ongoing basis as needed
  1. IVI electronic systems document management
  • Ensures proper maintenance of all GXP and organizational-level controlled documents, to include databases and systems in accordance with relevant GXP regulations, standards and guidelines (e.g., Trial Master Files, GCP essential documents)
  • Assists in implementation of corrective and/or preventive measures (in conjunction with QM and IVI stakeholders) to meet acceptable reliability standards and holds the responsibility for approving or rejecting (in conjunction with QM) all procedures impacting GXP environments
  • Partner with IVI Stakeholders and IT teams in ensuring documentation supporting software system validation is current and that documentation demonstrating IT related vendor and contractor qualification audits and approvals are current
  • Develop (in consultation with QM the IVI IT stakeholders) controlled and relevant documents for IVI electronic systems and individual projects in which IVI assumes a sponsor or collaborator role to ensure all GXP activities are aligned with regulatory requirements, standards, guidelines and IVI quality policy
  • Track and support implementation of IVI Annual Audit Plans as needed to ensure ongoing compliance with regulations, standards and guidelines and IVI controlled documents

 

Job Requirements and Qualifications

 

  1. Education Requirements
  • A Bachelor’s degree is required
  • A Master’s degree is preferred in biomedical field Qualified auditor/inspector license
  1. Related Field Work Experience
  • 5+ years QA, Bioanalytical experience, or related expertise in support of laboratory, manufacturing, clinical research supporting pharmaceuticals, biologics and/or medical devices
  1. Technical and Professional Skills / Knowledge
  • Certificates of GCP/GCLP online training, MFDS GLP training
  • Knowledge of GXP
  • Direct experienced with the validation of electronic systems (both COTS and internally developed), routine system management and change control
  1. Language Proficiency
  • Fluency in spoken and written English

Apply for job

 

출처: https://www.ivi.int/lab-quality-manager/

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