Sr. Manager - Infotech; Manufacturing Compliance Lead
Listed on 2025-12-28
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IT/Tech
IT Business Analyst, Cybersecurity, IT Support, Data Security
Location: Indiana
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Sr. Manager - Infotech (Manufacturing Compliance Lead)Company: Lupin
Job DescriptionManagement 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
PC based systems in manufacturing and quality domain
LIMS (Laboratory Information Management 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
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.
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