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Computer Systems Validation Professional

3 weeks ago

Tiruppur, Tamil Nadu, India beBeeComputerSystemsValidation Full time
About the Role

We are seeking a highly skilled Computer Systems Validation Professional to join our team. In this role, you will be responsible for executing GxP Computer System Validation (CSV) activities in accordance with industry standards and regulatory guidance.

The successful candidate will work collaboratively with project leads to ensure that systems are appropriately validated prior to release and remain in a compliant state throughout their lifecycle.

Key Responsibilities
  • Authoring, reviewing, and approving CSV deliverables, including change controls, system risk assessments, validation plans, user and functional requirements specifications, configuration specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and applicable SOPs.
  • Ensuring that testing is performed appropriately and test results are compiled in a timely manner.
  • Maintaining the validated state of client-supported GxP systems, including periodic review and release management.
  • Collaborating with offshore resources and onshore resources, requiring flexibility and availability until 11am PT US hours.
Requirements
  • Bachelor's degree in life sciences or engineering or pharmacy.
  • Knowledge of performing validation of cloud-based computer solutions and infrastructure qualification is a plus.
  • Ability to work on multiple projects simultaneously in a fast-paced environment with limited supervision.
  • Strong written and oral communication skills, with the ability to translate complex concepts across all levels of the organization.
Benefits

This is an excellent opportunity to work in a dynamic environment and contribute to the success of our clients. As a Computer Systems Validation Professional, you will have the chance to develop your skills and expertise while working on challenging projects.

You will be part of a talented team that values collaboration, innovation, and customer satisfaction. We offer a competitive compensation package and opportunities for growth and development.