QC Engineer

5 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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