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
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).
Experience: 5 – 10 years
Primary Skills (Must have)
Computer System Validation(CSV)
21CFR Part 820/Part 11