Senior QC Qualification Engineer - Validation & Compliance

No deviation Pte Ltd.

Singapore

On-site

SGD 90,000 - 180,000

Full time

4 days ago
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Job summary

No deviation Pte Ltd. in Singapore is seeking a Senior QC Qualification Engineer to own the qualification lifecycle for laboratory analytical computerized systems, from validation through decommissioning.

You will draft and execute validation documents, SOPs, and data integrity risk assessments, while coordinating with F&E, QA, QC and IT. The role emphasizes strong knowledge of GMP, GDP, and computerised system validation, with preference for biotech/pharma experience and familiarity with KNEAT

Qualifications

  • Biotech or pharmaceutical ops experience preferred.
  • Strong knowledge of validation approaches and GMP/GDP.
  • Familiarity with computerized system validation and temperature chamber qualification.
  • Experience with change control processes and data integrity.
  • Excellent communication and team collaboration.

Responsibilities

  • Own qualification lifecycle for lab analytical computerized systems.
  • Draft and execute Validation Plans, IOQ/PQ scripts, and reports.
  • Prepare SOPs for operations and maintenance.
  • Support preventive maintenance programs.
  • Coordinate with vendors and stakeholders across functions.

Skills

Communication
Teamwork
Independence
Data integrity

Tools

KNEAT

Job description

No deviation Pte Ltd. in Singapore is seeking a Senior QC Qualification Engineer to own the qualification lifecycle for laboratory analytical computerized systems, from validation through decommissioning.

You will draft and execute validation documents, SOPs, and data integrity risk assessments, while coordinating with F&E, QA, QC and IT. The role emphasizes strong knowledge of GMP, GDP, and computerised system validation, with preference for biotech/pharma experience and familiarity with KNEAT

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