Job Description

JOB RESPONSIBILITIES: IT Manager- (M3/M4)
IT Operations Management:
Management of site IT operations and routine support services to business.
Experience in facing regulatory inspections like USFDA, MHRA, EMA etc.
Good understanding on handling of GxP Applications/software implementation
IPC/HMI/Scada based System OSD equipment
PC based systems in manufacturing and quality domain
QMS system like caliber, Track-wise. etc
LIMS (Laboratory Information Management Systems
C-DAS (Central Data acquisition systems)
Chromeleon
MES Pas-X application
Execution and handling of Enterprise & site-specific software new implementations & upgrades.
Good understanding on handling of IT infrastructure/tools
Network components
Servers/database
Operating systems
Security tools
Maintain existing GxP applications and Handling of on-going application issues with minimal business and compliance impact.
IT Compliance Handling:
Knowledge of CSV as per GAMP, 21 CFR Part 11, EU Annexure-11 and compliance practices.
Strong exposure in Regulatory inspections like USFDA, MHRA, TGA, WHO etc.
Managing IT related change control, CAPA, deviations and incident etc.
Understanding of QC and manufacturing systems will be preferred.
Work Experience
Total 15 Years in IT Operation,
5 Years - GMP - IT Experience
10 Years as Site Head in IT operations
Btech, MTech
Competencies
Developing Talent
Innovation & Creativity
Result Orientation
Strategic Agility
Process Excellence
Customer Centricity
Collaboration
Stakeholder Management

Skills Required