Quality Control Manager

Happiest Minds Technologies

7 - 12 years

5 - 14 Lacs

Bengaluru

Posted:3 months ago| Platform:

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Skills Required

Csv Root Cause Analysis Change Management Compliance Process Management ITIL Capa Audit RCA Change Control ITIL Certified QMS Quality Control

Work Mode

Work from Office

Job Type

Full Time

Job Description

JD:

Mandatory Skills - ITIL, CSV, Process Management, Change Management, Pharma, audit, Compliance & Any certificate ITIL V3 / ITIL V4, CAPA, RCA

Global Quality IT Manager

Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems.
Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements.
Responsible for review/approval of IT infrastructure qualification documents, including enhancements.
Author & review CS-VMP and associated protocols & report templates.
Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability.
Support audit/assessment of suppliers of GxP IT Computerized Systems as SME.
Support Audit preparation and remediation activities, as appropriate.
Responsible for Monthly Reporting, as applicable.
Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems.
Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout.
Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable.
Report and escalate issues, as situation demands.
Perform other duties, as assigned.

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