QC Qualification Engineer (Lab Analytical Computerised Systems)

No deviation; Singapore; Presencial; SGD 90.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Leave policy

Health coverage

Career development

Inclusive culture

Descripción de la vacante

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.

Formación

• 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).

Conocimientos

Validation lifecycle

Data integrity

GMP/GDP knowledge

Communication skills

Collaboration

Independent worker

Herramientas

KNEAT

Descripción del empleo

Position Overview

We are seeking a Senior QC Qualification Engineer to own the qualification lifecycle of our laboratory analytical computerised systems, from validation through decommissioning. Responsibilities include managing change controls, drafting and executing validation documents (Validation Plans, IOQ/PQ scripts, summary reports and data integrity risk assessments), preparing operation and maintenance SOPs, supporting preventive maintenance programs, and coordinating with vendors and stakeholders across F&E, QA, QC and IT. The successful candidate will have strong knowledge of computerised system validation, lab instrument and temperature chamber qualification, data integrity, GMP and GDP. Experience in a biotech or pharmaceutical environment and familiarity with KNEAT or other electronic validation tools are preferred. Strong communication skills, a collaborative approach, and the ability to work independently with minimal supervision are essential.

Key Responsibilities

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

Requirements

• Related working experience in biotech or pharmaceutical operation environment is preferred.
• Strong understanding of various validation approaches, strategies and philosophies.
• Working knowledge of lab instruments and computerized system validation, controlled temperature chambers qualification etc.
• Working experience with KNEAT / electronic validation tools are preferred
• Experience with change control methodology
• Good knowledge in data integrity, GMP and GDP
• Good interpersonal skills / oral and communication skills.
• Ability to facilitate and work in a collaborative team-based environment.
• Team player with strong focus on safety, quality and timeline Able to work independently with minimal supervision

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.