IVY Works has an opening for full time employee as a Computerized System Validation Specialist or Engineer.
- Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
- Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
- Bachelor's degree in engineering / science.
- 2-3 years of work experience is a must.
- Experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Good communication and technical writing skills are a must.
Our Office is located in Bangalore and the job may involve travel to client locations.