IT Manufacturing Lead

2 days ago

Pune, Maharashtra, India Emcure Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Position Overview:

The Position includes key responsibility of management, support, and continuous improvement of GMP-compliant enterprise IT systems critical to pharmaceutical manufacturing and quality assurance processes. This role requires 10-15 years of experience with a strong background in OT and CSV, focusing on applications such as Quality Management Systems (QMS), Track and Trace, Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution System (MES) and other GMP enterprise systems. The candidate will lead the global IT OT team, ensuring compliance with regulatory standards while driving digital transformation initiatives.

Key Responsibilities:

  • Lead the management, maintenance, and enhancement of GMP IT enterprise applications including but not limited to QMS, MES, Logbook, Track and Trace, DMS, and LIMS.
  • Oversee Operational Technology (OT) systems supporting pharmaceutical manufacturing and quality operations globally.
  • Drive Collaborative initiatives within GXP Process and be a catalyst to drive digitization within the shopfloor by coordinating with Business stakeholders within Quality, Manufacturing, Compliance, and IT teams to align IT initiatives with business and regulatory needs.
  • Ensure all IT systems comply with relevant pharmaceutical regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11).
  • Develop and implement Computer System Validation (CSV) strategies and execution plans for new and existing systems.
  • Manage vendor relationships and coordinate third-party audits and validations from an IT and CSV perspective.
  • Lead cross-functional teams in system upgrades, implementations, and lifecycle management activities for all GXP systems.
  • Drive continuous improvement and digital transformation projects to enhance system capabilities and user experience.
  • Develop and deliver training and documentation to ensure user competence and system adherence.
  • Monitor system performance, risk management, and incident resolution processes.

Qualifications:

  • Bachelors or Master's degree in Information Technology, Computer Science, Engineering, or related field.
  • 10 plus years of progressive IT experience within the pharmaceutical or life sciences industry, with significant exposure to OT and CSV.
  • In-depth knowledge and hands-on experience managing GMP enterprise IT applications such as QMS, Track and Trace, DMS, and LIMS.
  • Proven expertise in Computer System Validation (CSV) methodologies and regulatory requirements (FDA, EMA, PIC/S).
  • Strong understanding of pharmaceutical manufacturing processes and quality systems.
  • Experience managing Operational Technology (OT) environments including SCADA, MES, and related automation systems.
  • Excellent project management, leadership, and communication skills.
  • Ability to work effectively in a global, matrixed environment.

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