Pharmaceutical Manufacturing IT Specialist

7 days ago

Meerut, Uttar Pradesh, India beBeeITProfessional Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Summary

This role is responsible for overseeing all IT operations within a manufacturing plant setting.

The ideal candidate will have a strong understanding of corporate IT standards and regulatory requirements, as well as experience working in a pharmaceutical manufacturing environment.

Key Responsibilities:
  • IT Operations Management

Manage all IT systems, infrastructure, and networks to ensure optimal performance and alignment with corporate standards.

System Support and Validation

Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA) and ensure proper documentation and validation protocols are followed.

IT Liaison

Act as the primary IT contact for plant and quality assurance teams, ensuring seamless communication and collaboration.

Audit Readiness

Support audits and inspections by regulatory bodies (FDA, EMA) 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 to protect against potential threats.

IT System Rollouts

Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.

IT SOPs

Maintain and update IT Standard Operating Procedures (SOPs) in compliance with GxP standards.

Vendor Management

Collaborate with vendors and third-party service providers for support and maintenance of plant systems.

User Training

Train and support end-users on relevant IT systems and best practices.

Qualifications & Skills:
  • Education

Bachelor's degree in computer science or related field.

Experience

3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.

Regulatory Knowledge

Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.

System Experience

Experience supporting or managing systems such as MES, LIMS, SCADA in a GMP environment.

Process Knowledge

Familiarity with ITIL processes and system validation life cycle (SDLC).

Soft Skills

Strong troubleshooting, analytical, and communication skills.

Project Management

Ability to manage projects and coordinate cross-functional teams.

Audit Participation

Experience with audit readiness and participation is a strong advantage.

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