Instrumentation-and-control-solutionis looking for #Computer_System_Validation Engineer with Multiple location so please check and apply .
Job Profile-CSV Validation Engineer
Qualification-BE- EC/EE/EI/Any
Experience-Minimum 06- 4 Years Preferred
Location- #Indore #Mumbai #Tarapur #Baddi #Nagpur #Aurangabad
Salary- Best Hike on Current Salary
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
4-Hands of experience in Verification and Validation of Laboratory Instruments (QC) and applications
5-Performing Gap Analysis for legacy systems.
6- Extensive knowledge on the GxP disciplines and 21CFR Part 11, EU Annex 11.
Interested please share your resume at ankur.tiwari@ics-india.co.in
You can directly call/ WhatsApp me on 8839091020
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