Sr. Manager - Infotech (Manufacturing Compliance Lead)

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Date: Jul 15, 2024

Location: Airoli, IN

Company: Lupin

Brief JD -

  • Collaborate with leadership from Production, Quality, Engineering, Subject Matter Experts (SMEs) for effective and successful application implementation in defined timelines.
  • Experience in facing regulatory inspections like USFDA, MHRA, EMA etc.
  • Excellent skills of resource handling and people management
  • Good understanding on handling of GxP Applications/software implementation
    • IPC/HMI/Scada based System.
    • 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
  • Good understanding of Enterprise & site-specific software new implementations & upgrades.
  • Good understanding on handling of IT infrastructure/tools
    • Network components
    • Servers/database
    • Operating systems
    • Security tools
  • Harmonization and Implementation of best-in-class practices & procedure to improve IT efficiency and compliance.
  • Management of application vendors, implementation partners and other support teams.
  • Stakeholder and Conflict management.

IT Compliance Handling:

  • Knowledge of CSV as per GAMP, 21 CFR Part 11, EU Annexure-11 and compliance practices.
  • Excellent skills in investigation report & SOP writing
  • Good understanding of QC and manufacturing systems in line with Data integrity aspect.
  • Ensure IT application activities are executed according to regulatory compliance standards and IT security norms.
  • Excellent Understanding on IT related change control, CAPA, deviations and incident etc.  
  • Good Skills to deliver training across the IT domain.
  • Participating in periodical SOP reviews and facilitating for various internal/External audits.
  • Budget management and cost monitoring.
  • Any additional responsibilities as assigned

 

Experience - 15+ Years in Pharma IT

 

Qualification - B.E / B.Tech

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