Validation Engineer - 5 to 10 Yrs - Bangalore

Validation Engineer - Bangalore - 5 to 10 Yrs:

We are looking to hire Validation (CSV) Testers with 5 – 10 years of exp in Bangalore location.

 

Role Description (Role & Responsibilities):

Estimate the work and maintain communication with onshore lead (if required can directly interact with client) 

Experience in User Expectance testing and stake holder management 
Excellent Communication

Specification / Skills / Experience:

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).

 

Location:  Bangalore

Experience: 5 – 10 years

Primary Skills (Must have)
Computer  System Validation(CSV)

GAMP5

21CFR Part 820/Part 11

Contact
Sushma Vedula