Test Lead 1

Short Description

Validation Testing or CSV  – 6 to 9 years 

 

 We are looking to hire Validation Testing or CSV  with 6 – 9 years of exp in Bangalore location

 

Role Description

 

7+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry. 

5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices). 

Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.

Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.  

 

Location: Bangalore   

Experience: 6 – 9 years

 

Primary Skills (Must have)

Validation Testing or CSV  

 

Contact

 Sajith Nair