As a QC Engineer, you will manage temperature mapping studies, prepare validation documents, ensure compliance with industry standards, and collaborate for audit readiness.
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.
- 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.
Top Skills
Kneat
Unison Consulting Singapore Office
1 Changi Business Park Crescent, , Plaza 8 #03-06 Tower A, Singapore, , Singapore, 486025
Unison Consulting Singapore Office
#12-00, 63 Market Street, Bank of Singapore Center, Singapore, , Singapore, 048942
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