Pharmaceutical Manufacturing IT Specialist

1 day ago

Solapur, Maharashtra, India beBeeITProfessional Full time ₹ 20,00,000 - ₹ 25,00,000
Job Summary:

We are seeking an experienced professional to manage all IT operations at a manufacturing plant.

This role will ensure alignment with corporate standards and regulatory requirements, providing GxP-compliant support for manufacturing systems and collaborating with vendors and third-party service providers.

Key Responsibilities:

  • IT Operations Management: Manage all IT operations at the manufacturing plant, ensuring alignment with corporate standards and regulatory requirements.
  • GxP-Compliant Support: Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed.
  • IT Contact: Act as the primary IT contact for plant and quality assurance teams.
  • Audit Support: Support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance.
  • Infrastructure Management: Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support.
  • Cybersecurity: Implement and monitor cybersecurity protocols in the plant environment.
  • IT System Rollout: Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.
  • SOP Maintenance: Maintain and update IT SOPs in compliance with GxP standards.
  • User Training: Train and support end-users on relevant IT systems and best practices.

Qualifications & Skills:

  • Bachelor's degree in computer science or related field.
  • 3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.
  • Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.
  • Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment.
  • Familiarity with ITIL processes and system validation life cycle (SDLC).
  • Strong troubleshooting, analytical, and communication skills.
  • Ability to manage projects and coordinate cross-functional teams.
  • Experience with audit readiness and participation is a strong advantage.

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