Sr. Manager - Infotech (Manufacturing Compliance Lead)

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Date: Dec 26, 2025

Location: Airoli, MH, IN

Company: Lupin

Job Description

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

15+ Years in Mfg IT & CSV & Compliance

Education

Competencies

Developing Talent
Innovation & Creativity
Result Orientation
Strategic Agility
Process Excellence
Customer Centricity
Collaboration
Stakeholder Management

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