Validation Specialist API

sun pharma industries

7 - 8 years

6 - 7 Lacs

bharuch

Posted:4 days ago| Platform:

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Skills Required

computer system validation remediation cqa usage edms pharma continuous improvement information technology operations auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

To manage the Inventory of GxP Applications for Manufacturing Quality IT.
To support the Planning and review of validation deliverables for CSV Projects.
Support in Preparation, reviews and Approval of Computer System Validation (CSV) documents as per implemented processes as Technical Owner.
Ensuring the compliance of GSOP s/SOP s related to Computer System Validation documentation and regulatory requirements during execution of CSV Project.
Detailed understanding for the working and usage of systems such as Trackwise, Validator and EDMS.
Compliances to IT policies and procedures regulatory requirements and support for the internal and external audits and remediation.
Vendor coordination and support during Installation qualification (IQ), Operational qualification Performance qualification (PQ).
Identify the continuous improvement opportunities for CSV projects.
Documentation and control for management of IT CSV Documents.
Timely completion of validation activities with zero timeline extensions
Full audit readiness with complete and compliant documentation
Effective and timely closure of all related QMS records (deviations, CAPA, change controls, etc.)

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