Computer Systems Validation Consultant

Description:

Our client is specializing in customized technology solutions, the company focuses on enhancing operational efficiency and performance across diverse industries. Their services encompass software development, IT consulting, cybersecurity solutions, and managed IT services. They are committed to delivering innovative solutions tailored to specific client needs, promoting sustainable growth and operational excellence through advanced technology.

The consultancy focuses on major life sciences players and primarily servicing global TOP80 organization.

Position Summary: The Computer Systems Validation (CSV) Consultant will be responsible for ensuring that computerized systems used in the development, manufacturing, and distribution of pharmaceuticals, medical devices, and other healthcare products comply with regulatory requirements and operate effectively. The consultant will develop validation plans, create documentation, execute tests, and manage compliance to regulatory standards.

Key Responsibilities: The CSV Consultant will develop and maintain comprehensive validation plans, prepare validation documentation including user requirements and test scripts, conduct and oversee installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) tests, and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations. Additionally, the consultant will identify and mitigate risks, provide training and support to end-users, prepare for audits, manage change control processes, and collaborate with software and hardware vendors.