Senior QA Analyst

Bachelor's degree in engineering / science.

3+ years of experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

Experience with the implementation of Quality Management systems (Track wise/ Master control / ETQ/ CEBOS)

Should be able to Develop validation documentation for pharmaceutical equipment, facilities and

computerized systems used in GLP, GMP and GCP environments.

Should be able to create project Deliverables which will encompass validation plans, specifications, test protocols and standard operation procedures

Good communication and technical writing skills are a must.

Should be able to work Independently.

Should be Flexible to handle multiple projects parallelly.

Should have experience in Managing clients and Stakeholder.

Strong Manufacturing or Business process knowledge will be added advantage.

Any Automation skill set /ability is added advantage

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com