Computer System Validation
2 weeks ago
Hiring for Instrumentation-and-control-solution
Job Profile-CSV Validation Engineer
Qualification-BE- EC/EE/EI
Experience-Minimum 2 Years
Location
- Indore,Baddi
Salary
- Best hike from current market
Roles & Responsibility
- 1-A CSV engineer will use his/her knowledge of FDA CGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs.
**2-Performing GxP Assessments**
**3-Hands on experience in Verification and Validation of the computer system starting from preparation of Validation Plan, Specification documents, Risk Assessment, Infra Qualification/Server Qualification, IQ. OQ & PQ Protocol, Traceability Matrix, and 30997* Validation Report as per the classification of GAMP 5, USFDA guidelines and Good Documentation Practice**
**5-Performing Gap Analysis for legacy systems.**
**6- Extensive knowledge on the GxP disciplines and 21CFR Part 11, EU Annex 11.**
**7-Strong in concepts of Testing Life Cycles like V-Model.**
**8-In depth knowledge of Computerized Systems Validation, System Development Life Cycle (SDLC), General Principles of Software Validation.**
Perk & Benefits
- #PF
ESIC
Allowances
Accomodation
You can directly call/ WhatsApp me on 9109188512
Pay: ₹15,000.00 - ₹50,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Food provided
- Health insurance
- Life insurance
- Paid sick time
- Provident Fund
Schedule:
- Morning shift
Supplemental Pay:
- Shift allowance
Work Location: In person
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