Validator & Medhas Support Job Vacancy in Sun Pharmaceutical Industries, Inc. Mumbai, Maharashtra – Updated today

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Full Details :
Company Name : Sun Pharmaceutical Industries, Inc.
Location : Mumbai, Maharashtra
Position :

Job Description : Title: Validator & Medhas Support
Date: Feb 18, 2022
Location: Sun House – Corporate Office
Company: Sun Pharmaceutical Industries Ltd
Accountabilities:
SDLC document creation, review for new GxP system based on GAMP 5 (specialized in category 4 and 5 system)
Supporting overall qualification and compliance activities.
Development of protocols for the validation of complex computer systems which includes ability to develop Installation, Operational and Performance qualification documents.
Software application Testing, Risk based front end testing.
Conduct Periodic Training sessions for Paperless Validation and cGxP application’s inventory management/User access management applications .( Cat 4 and 5 applications)
Prepare, review, execution and summarization of validation protocols.
UPD, Incident, Change Control, Bug Fix, TPR Activities support.
User Access management for Validator and Medhas application.
ITSM Incident Management – ticket Monitoring and providing support to application users.
Assisting periodic Validation review, Periodic User Access Right Review activities for paperless validation and inventory management applications.
Participation in GxP and 21CFRPart 11 assessment for upcoming CSV project activities.
Evaluating applications readiness for 21 CFR Part 11 as per the FDA regulatory guidelines.
Proficient in making validation deliverables like Risk Assessment, ERES Assessment, VP, URS, FRS, DS, RTM and VSR.
Periodic review of system’s validation documents and SOP’s.
Gap Analysis and Risk Assessment of the existing system as per project requirements.
Review of validation deliverables.

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