QC Engineer

4 days ago

Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

We are seeking a QC Engineer with hands-on experience in temperature mapping of controlled chambers. The role focuses on validation, documentation, and compliance with GDP and ALCOA+ principles to ensure the reliability of temperature-controlled environments in a regulated setting.
Key Responsibilities
Plan and execute
temperature mapping studies
for chambers such as cold rooms, freezers, incubators, and stability chambers.
Prepare and review protocols, reports, and validation deliverables using systems such as
Kneat .
Perform
data integrity assessments
and ensure compliance with GDP and ALCOA+ principles.
Draft, review, and maintain
SOPs
related to temperature mapping and qualification activities.
Support
audit/inspection readiness
through accurate documentation and reporting.
Collaborate with QC, QA, and Engineering teams to ensure compliance and operational readiness.
Contribute to process improvements for chamber qualification and environmental monitoring.
Requirements
Bachelor’s degree or Diploma in Life Sciences, Engineering, or related discipline.
2–5 years’ experience
in
temperature mapping
of chambers within pharmaceutical/biotech or regulated industries.
Knowledge of
GDP, ALCOA+ principles , and validation requirements.
Experience with
protocol drafting
and use of electronic validation systems (e.g., Kneat) is advantageous.
Strong analytical and documentation skills.
Ability to work cross-functionally and support compliance initiatives.
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