Manager - CQIT

Position:

Manager-1

Job Title:

Manager IT Compliance

Job Location

 Mumbai

Function:

CQ IT

Sub-function:

CQ IT Compliance

Areas of Responsibility

To ensure compliance of all GxP computerized systems as per Sun CS QMS and regulatory requirements. Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls. Review of computerized systems of manufacturing systems. Emerging and Application of user privileges or access rights for entire Manufacturing computerized systems. Overseeing the Manufacturing IT Compliance Viz., Setting & Verification of Security policies, Periodic Backup & Restoration activity, Investigation of backup failures, Verification windows OS policies and Active users lists for entire of Manufacturing computerized systems. Review of OEM and CSV qualification documents for manufacturing systems. Conduct Gap Assessment of GxP Computerized systems installed at Manufacturing area. Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps

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