Validation Testing

We have Opportunity for Validation testing for Capgemini-Bangalore.

 

Experience Required:-7 years-10 years

Technical Skill Required:-

To independently drive / support Software Validation (Regulatory & Compliance) process in healthcare sector. Part of the Quality & Regulatory Operations, responsibility is to meet regulatory requirements in the validation of various IT applications. Primary Responsibilities include: 

Skills: 1. Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines. 2. 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. 3. Bachelor’s degree (BSEE) in engineering and IT related fields; but any advanced degrees are preferable in Quality, Regulatory or Software Engineering. 4. 7+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry. 5. 5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).
 

Thanks

Subhashree