Csv
3 days ago
Work Location: Remote
Experience: 3+ Years
Who we are:
We are an ISO 27001 certified innovative and value driven company in the business of Software
Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA,
Data Analytics & Business Intelligence. We have our India offices in Bangalore, Hyderabad, Kochi and
onsite offices in US and Canada. We have been able to work in multiple projects in various domains
ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of
the industry leaders in these areas.
Key Responsibilities:
- Should have 3 to 10 years’ experience in computer system validation or testing experience in
the Life sciences domain.
- Good Knowledge of 21 CFR Part11, Annex11 and GAMP5
- Be accountable for authoring key CSV deliverables - URS/FRS, Validation Plan, RTM and
Validation Summary Report
- Requirements Analysis and Functional Risk Assessment, Profiling and Mitigation in
collaboration with the SME
- Reviewing and authoring of the Qualification scripts (IQ, OQ, PQ scripts, results and reports)
- Closely work with clients and product owners to support implementation and
resolve product issues.
Qualification:
- BE/B Tech/MCA
-
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