Life Science Validation Expert

1 week ago

Singapore beBeevalidation Full time $80,000 - $120,000

Are you a detail-oriented and organized professional looking to make a meaningful contribution to the life science industry?

We are seeking a highly skilled Validation Specialist to join our team.

About the Role

This is an exciting opportunity for someone who enjoys working on computer system validation, change control processes, and quality management processes. As a Validation Specialist, you will contribute to Life Science projects for clients, manage change control processes, and ensure accurate documentation, risk assessment, and approval workflow.

You will also be responsible for coordinating with relevant departments to assess the impact of changes and ensuring successful integration into existing systems, supporting Corrective and Preventive Actions (CAPA), conducting root cause analysis, and implementing effective solutions.

In addition, you will utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking, develop and configure TrackWise workflows, and ensure proper documentation.

You will also develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance, document test results, deviations, and corrective actions, and ensure alignment with validation protocols.

Our ideal candidate will have a Bachelor's degree in Computer Science, Life Science, or a related field, 1-2 years of experience in validation of computer systems in the pharmaceutical industry, proficiency in Kneat, TrackWise, CAPA, and change control processes, and familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).

If you are motivated, able to work independently as well as in a team, and possess good organizational and oral and written communication skills, we encourage you to apply.

Key Responsibilities
  • Contribute to Life Science projects for clients
  • Manage change control processes
  • Coordinate with relevant departments
  • Support Corrective and Preventive Actions (CAPA)
  • Utilize and manage TrackWise
  • Develop and configure TrackWise workflows
  • Develop and execute validation test scripts
  • Document test results, deviations, and corrective actions
Requirements
  • Bachelor's degree in Computer Science, Life Science, or a related field
  • 1-2 years of experience in validation of computer systems in the pharmaceutical industry
  • Proficiency in Kneat, TrackWise, CAPA, and change control processes
  • Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5)
What We Offer

We offer a competitive salary and benefits package, opportunities for career growth and development, and a dynamic and supportive work environment.

About Us

We are a leading provider of software and services to the life science industry, committed to delivering high-quality solutions that meet the needs of our clients.

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