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Sr QA Technician

Location Singapore, 新加坡 Job Id R-01304305 Job Type 全职 Category 质量与注册 Remote 全面驻场
JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

Become an integral part of the ambitious QA team at Thermo Fisher Scientific Inc. as a Quality Specialist I. This role is pivotal in ensuring our manufacturing processes are of world-class quality and strictly adhere to GMP requirements. Collaborate with a team driven to implement flawless quality systems and successfully meet corporate standards and regulatory compliance.

Responsibilities

  • Ensure the safety message is lived throughout the organization, promoting a culture of safety.
  • Coordinate document and record management systems; coordinate site document management requirements, including document printing, reconciliation, and archival.
  • Ensure all documents follow approved instructions and that completed records are archived accurately.
  • Coordinate site training and personnel qualification, improving GMP training modules.
  • Ensure timely completion and efficiency checks of CAPAs.
  • Manage corporate standards gap assessment, ensuring site compliance with regulatory requirements.
  • Support and continuously improve the site self-inspection program, including developing annual plans, and performing periodic reviews and trend analyses.
  • Coordinate inspection readiness activities, preparing the site for client and regulatory audits.
  • Participate in audits, ensuring smooth execution and compliance.
  • Adhere to and support the implementation of site data integrity systems.
  • Complete any additional related tasks as assigned.

EHS

  • Understand and ensure implementation of emergency procedures and safe work systems.
  • Ensure compliance with environmental, health, and safety rules and prompt reporting and investigation of incidents.

Minimum Requirements/Qualifications

  • Education: Diploma or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field.
  • Experience: 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may be considered.
  • Proficiencies: Understanding of cGMP and regulatory compliance, strong communication and collaboration skills, problem-solving capabilities, and knowledge of quality risk management.

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