CSV/CSA Consultant from Collabera

Job title: CSV/CSA Consultant

Location: Remote

Pay rate : $60-63/hr

DayToDay Responsbilities:

As a CSV/CSA Consultant, you will play a critical role in ensuring the compliance of our computer systems with relevant regulations such as 21 CFR Part 11 and GAMP 5.

You will be responsible for conducting risk assessments, developing validation plans, executing validation protocols, and maintaining compliance documentation.

Responsibilities:

• Conduct risk assessments for computer systems used in regulated environments.


• Develop and execute comprehensive validation plans, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).


• Author and review validation documentation (e.g., protocols, reports, deviations).


• Ensure compliance with applicable regulations (e.g., 21 CFR Part 11, GAMP 5).


• Support the implementation and maintenance of CSV processes.


• Stay abreast of evolving regulatory requirements and industry best practices.


• Experience with ServiceNow validation is a plus.