QC Engineer

6 hours ago

Singapore Unison Consulting Pte Ltd Full time

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.
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.
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