Senior QC Validation Engineer – Analytical Systems

No deviation Pte Ltd; Singapore; Presencial; SGD 90 000 - 150 000; Tempo integral

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Leave policy

Health coverage

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Inclusive culture

Resumo da oferta

No deviation Pte Ltd is seeking a Senior QC Qualification Engineer to own the qualification lifecycle of laboratory analytical computerized systems, from validation through decommissioning. Responsibilities include drafting validation documents, managing change controls, and coordinating with F&E, QA, QC and IT.

The ideal candidate will have strong knowledge of computerised system validation, data integrity, GMP and GDP, and experience in biotech or pharmaceutical environments.

Qualificações

• Experience in biotech or pharmaceutical operation environment.
• Understanding of validation approaches, strategies and philosophies.
• Working knowledge of lab instruments and computerized system validation.
• Familiarity with KNEAT or electronic validation tools.
• Experience with change control methodology.
• Good knowledge in data integrity, GMP and GDP.
• Good interpersonal and communication skills.
• Ability to facilitate and work in a collaborative team-based environment.

Responsabilidades

• Support Change Controls initiation and end-to-end ownership for lab Analytical Computerised System Qualification.
• Draft and execute Validation documents (Validation Plan & Requirement, IOQ/PQ Test Scripts, Summary report, Data Integrity Risk Assessments).
• Draft Decommissioning related documents (Decommissioning plan, summary report).
• Draft Operations and Maintenance SOPs.
• Support in generation of Preventive Maintenance program for System.
• Coordinate with equipment vendor for vendor qualification activities.
• Coordinate with stakeholders (F&E, QA, QC, IT).

Conhecimentos

Validation lifecycle

Data integrity

GMP/GDP knowledge

Communication skills

Collaboration

Independent worker

Ferramentas

KNEAT

Descrição da oferta de emprego

No deviation Pte Ltd is seeking a Senior QC Qualification Engineer to own the qualification lifecycle of laboratory analytical computerized systems, from validation through decommissioning. Responsibilities include drafting validation documents, managing change controls, and coordinating with F&E, QA, QC and IT.

The ideal candidate will have strong knowledge of computerised system validation, data integrity, GMP and GDP, and experience in biotech or pharmaceutical environments.