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QC Engineer - Temperature mapping

QC Engineer - Temperature mapping

Unison GroupKuala Lumpur, Kuala Lumpur, Malaysia
12 hari lalu
Penerangan pekerjaan

Overview

We are looking for a QC Engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification, documentation, and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting.

Base pay range

SGD48,000.00 / yr - SGD72,000.00 / yr

Responsibilities

  • Plan, execute, and document temperature mapping studies for chambers (cold rooms, freezers, incubators, stability chambers)
  • Prepare and review validation protocols, reports, and deliverables in Kneat or equivalent systems
  • Perform data integrity assessments and ensure compliance with GDP and ALCOA+ principles
  • Draft and maintain SOPs for temperature mapping and chamber qualification
  • Support deviation management, change control, and CAPA implementation
  • Provide technical input for requalification planning and continuous improvement
  • Collaborate with QC, QA, and Engineering to support audit and inspection readiness

Qualifications

  • Good experience in temperature mapping of chambers within pharmaceutical / biotech or regulated industries
  • Knowledge of GDP, ALCOA+ principles, and qualification practices
  • Familiarity with mapping across a variety of chambers is advantageous
  • Experience with validation documentation and use of Kneat preferred
  • Strong technical writing, data review, and teamwork skills
  • Seniority level

  • Associate
  • Employment type

  • Full-time
  • Job function

  • Information Technology
  • Industries

  • IT Services and IT Consulting
  • #J-18808-Ljbffr

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