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Job ID :
51474BR
Location :
South Korea - Seoul
:
Job Description
Quality Associate
Based in Gangseo office

Position Summary: The associate is to ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Logistics approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Korea Quality System in compliance with Fisher Clinical logistics approved procedure and policies, cGMP, cGDP, and regulatory requirements and guidelines. Liaise with clients, internal and external customers on quality related matters. Also to ensure that supplies, facility and processes are maintained to cGMP standards.

Essential Duties and Responsibility:
  • To ensure that all processes are performed in accordance with cGMP
  • To ensure services and processes perform in the company are in compliance with local regulatory and policies
  • Document control management, in alignment with Network Quality standards.
  • Perform pre and post review of production batch records and label printing records
  • (if applicable)
  • Prepare new and update existing job related Standard Operating Procedures (SOPs)
  • Conducts internal audits according to SOP requirement and assist in regulatory, supplier and client audits.
  • Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
  • Write and/or review problem report to ensure the quality of the report produced
  • Assist in managing the QA/GMP training of employees across the company
  • Responsible for the release of client supplied materials and Fisher supplied materials
  • Approval of component and material specifications
  • Perform periodic checks on the accuracy of picked drug supplies against client orders and shipping distribution documents
  • Responsible for in-process check for Just-In-Time Labeling and in-process inspection during production job runs
  • Perform ad-hoc duties as requested by line management
Minimum Qualifications:
  • Bachelor's degree in life sciences or related medical/scientific field
  • Previous working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance and regulatory affairs; Licensed Pharmacist preferred
  • Good organizational skills and the ability to manage multiple tasks
  • Meticulous attention to detail
  • Good written and verbal communication skills
  • Computer Literate
  • Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
  • Ability to work independently



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