Software Systems Integrity Specialist

1 week ago

Singapore beBeeValidation Full time $90,000 - $120,000
Job Title:

Validation Specialist

Job Description

About us:

We are a dedicated team that provides patient-centric solutions for the pharmaceutical industry. Our goal is to deliver innovative and effective solutions that meet the needs of our clients.

As a Validation Specialist, you will play a key role in ensuring the quality and integrity of our systems and processes. You will be responsible for planning and executing validation activities associated with software upgrades and decommissioning of legacy computerized systems.

You will work closely with our QC and IT teams to ensure accurate integration of system requirements and compliance with data integrity expectations.

The ideal candidate will have a strong understanding of GAMP 5, FDA 21 CFR Part 11, and Annex 11 requirements. They will also have experience in system decommissioning and data migration strategies.

Responsibilities include:

  • Planning and executing validation activities associated with software upgrades
  • Developing and reviewing validation documentation including URS, risk assessments, protocols (IQ/OQ/PQ), and summary reports
  • Collaborating with QC and IT teams to ensure accurate integration of system requirements and compliance with data integrity expectations
  • Leading or supporting the decommissioning of computerized systems used within the QC lab
Required Qualifications
  • Bachelors Degree in Life Sciences, Engineering, Computer Science, or a related discipline
  • Proven experience in validation of computerized systems in a GMP laboratory or manufacturing environment
  • Strong understanding of GAMP 5, FDA 21 CFR Part 11, and Annex 11 requirements
  • Experience in system decommissioning and data migration strategies
Benefits
  • Comprehensive health and wellness coverage
  • Professional development opportunities
  • Inclusive culture

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