Medhas & Validator Support Job Vacancy in Sun Pharmaceutical Industries, Inc. Mumbai, Maharashtra – Latest Jobs in Mumbai, Maharashtra
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Company Name : Sun Pharmaceutical Industries, Inc.
Location : Mumbai, Maharashtra
Position :
Job Description : Title: Medhas & Validator Support
Date: Feb 24, 2022
Location: Sun House – Corporate Office
Company: Sun Pharmaceutical Industries Ltd
Job Profile and Expected Key Outcomes:
Computer Systems Validation Operations: Supporting Computer System Validation activity for multiple Applications including planning, Implementation, Application Support, vendor management and co-ordinating with the stake holders.
Handling system administrator role for (Validator & Inventory – UAM Management tool) Cat-4 and cat-5 application. Co-ordinate with Sun Pharma’s CSV quality & compliance team for the objectives and alignment of compliance activities
Active participation in Preparing and authoring validation deliverables like Risk Assessment, ERES Assessment, URS, FRS, DS, RTM and Test Plans, Design Specification, Configuration Specification, CSAP,DR & BCP Plans. Handling end to end Test management activities, building Test Plan, Test Reports, RTMs
Conducting periodic training of CSVLMS (Paperless Validation tool) and Inventory – UAM Management application for PAN India and international users.
Assisting new release, implementation and patch management activities of Validator and cGxP applications Inventory management application.
Excel in risk based testing Software, Web Applications, and System Components. Exposure to Protocol Creation, Review & execution –IQ, OQ, PQ
Maintain and store original QMS documents such as (change controls, Incident Reports, Issues Tracker, TPR’s etc.).
Ensure location wise user training completion status for Application GSOP/ Site Specific SOPs and maintaining the training records for audit purpose.
Ensure timely closure of all the incidents, CAPA and maintain the QMS tracker for monitoring pending QMS activities.
Handling identity and access management for various application and platforms.
Managing all ongoing projects for service management, incident and escalations management for ITSM application support tickets.
Raising and Reviewing of Change controls, deviations, CAPA, Out of specifications, out of limit for microbial monitoring activities.
Assisting team member in test management and CSV activities for other project qualification activities (Viz LIMS, EDMS etc.).
Identify areas of improvement within the CSV space as per learnings from multiple project implementation.
Participate during Computer system Development /implementation to ensure that the solution meets to the regulatory requirements.
Review of validation deliverables.
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