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QC Engineer - Temperature mapping
Unison GroupKuala Lumpur, Federal Territory of Kuala Lumpur, MY18 jam yang lalu
Jenis pekerjaan
- Quick Apply
Penerangan pekerjaanGood 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.
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.
- 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.
Requirements
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Engineer • Kuala Lumpur, Federal Territory of Kuala Lumpur, MY
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