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
· 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.
Collaborate with QA, Engineering, and Operations to ensure compliant practices
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.
Strong documentation skills
Top Skills
What We Do
Unison Consulting was launched in Singapore on September 2012, the hub of the financial industry, with innovative visions in the technocratic arena. We are a boutique next-generation Technology Company with strong business-interests in Liquidity risk, Market Risk, Credit Risk and Regulatory Compliance.
Unison provides technology consulting and services to implement Risk Management and Risk Analytics System for Financial Institutions. Our services suite comprises of Techno-Functional consulting, systems integration, Business Intelligence, information management, and custom development of IT solutions, plus project management expertise for financial institutions.
We have expertise in latest cutting edge technology to achieve better total cost of ownership. Through our qualified professionals, we assist you drive your unique risk management strategies, whether that means efficient monitoring, improving risk appetite of the financial institutions, complying with regulations, or capturing growth opportunities through innovation, this is what maximizes your decision taking potential. At Unison Consulting, we view clients as partners, and our success is only measured by the success of our partners. So we put it all on the table in order to exceed expectations.
Our staff consists of young, energetic and innovative consultants who are never afraid to challenge the conventions and push the boundaries in an effort to help our clients. For every project, no matter how large or how small, we strive to not only meet your needs, but deliver a showcase in your field
