Sr. Manager - Infotech (Manufacturing Compliance Lead)

Lupin; Navi Mumbai; On-site; INR 12,00,000 - 15,00,000; Full time

Job summary

A leading pharmaceutical firm in India is seeking a Sr. Manager - Infotech. You will manage IT operations and routine support services, ensuring compliance with regulatory inspections including USFDA and MHRA. The ideal candidate will have a strong understanding of GxP applications and experience in handling software implementations in the manufacturing domain. This role involves addressing application issues and managing change control processes within IT environments.

Qualifications

• Experience in facing regulatory inspections like USFDA, MHRA, EMA.
• Knowledge of CSV as per GAMP, 21 CFR Part 11, EU Annexure-11.
• Strong understanding of handling GxP Applications/software implementation.

Responsibilities

• Management of site IT operations and routine support services.
• Maintain existing GxP applications and handle application issues.
• Managing IT related change control, CAPA, deviations, and incidents.

Tools

LIMS

Chromeleon

MES Pas-X

Job description

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Sr. Manager - Infotech (Manufacturing Compliance Lead)

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

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.