CQV Engineer - Temperature Mapping
Unison GroupSingapore10 hours ago
Full-timeInformation Technology
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Role Overview
We are seeking a CQV Engineer with specialized experience in temperature mapping of controlled temperature chambers in GMP/GDP environments. The role requires strong knowledge of GDP principles, ALCOA data integrity standards, and experience authoring protocols and reports in Kneat.
Key Responsibilities
Requirements
We are seeking a CQV Engineer with specialized experience in temperature mapping of controlled temperature chambers in GMP/GDP environments. The role requires strong knowledge of GDP principles, ALCOA data integrity standards, and experience authoring protocols and reports in Kneat.
Key Responsibilities
- Plan and execute temperature mapping studies for a variety of controlled chambers (refrigerators, freezers, incubators, warehouses, etc.)
- Draft and execute validation protocols, reports, and data integrity assessments
- Perform equipment qualification activities (IQ/OQ/PQ) in compliance with GDP and ALCOA principles
- Develop and review SOPs, deviation reports, and CAPAs related to temperature mapping
- Support audits and inspections by providing validation evidence
Requirements
- Bachelor's degree in Engineering, Life Sciences, or related field
- Experience in temperature mapping and qualification activities
- Strong knowledge of GDP and ALCOA principles
- Experience drafting protocols and reports in Kneat preferred
- Familiarity with a wide range of temperature-controlled chambers advantageous
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