IT Manager (Infrastructure, Networking and GxP Systems)

Job Title: IT Manager Infrastructure, Networking & GxP Systems

Location:

Department:

Job Summary:

IT Manager

Key Responsibilities:

1. IT Infrastructure & Networking Management

• Oversee

  IT infrastructure

  , including

  servers, storage, networking, and data centers

  .
• Manage enterprise

  LAN/WAN, VPN, and cybersecurity solutions

  .
• Ensure

  high availability and performance

   of IT systems supporting production and QC.
• Work with

  external vendors and service providers

   for IT support and upgrades.

2. Production & QC Instrumentation Support

• Manage and support

  GxP-compliant IT systems

   used in

  manufacturing and quality control (QC)

  .
• Ensure seamless integration of

  production instruments (e.g., PLCs, SCADA)

   with enterprise IT systems.
• Oversee

  QC instrumentation

   (e.g., HPLC, GC, UV, FTIR, and other lab equipment) from an IT compliance perspective.
• Ensure

  21 CFR Part 11

   and

  data integrity

  compliance for QC systems.

3. Regulatory Compliance & IT Validation

• Implement

  IT policies and procedures

   to comply with

  USFDA, MHRA, EU GMP, WHO, and other regulatory bodies

  .
• Lead

  IT validation and qualification (IQ, OQ, PQ)

   for production and QC systems.
• Ensure

  audit readiness

   and participate in

  regulatory inspections

   related to IT systems.
• Maintain

  IT SOPs, risk assessments, and CAPA documentation

  .

4. Security & Business Continuity

• Implement and maintain

  IT security frameworks

   (e.g., ISO 27001, NIST).
• Ensure

  backup, disaster recovery, and business continuity

   plans are in place.
• Monitor and respond to

  IT security incidents

   and ensure

  data protection

  .

5. Stakeholder Collaboration

• Collaborate with

  Production, QA, QC, Regulatory Affairs, and Engineering teams

   to align IT with business goals.

Required Qualifications & Experience:

• Bachelor’s/Master’s degree

   in

  Information Technology, Computer Science, or a related field

  .

• 18+ years of experience

   in IT management within a

  pharmaceutical manufacturing site

• Expertise in

  IT infrastructure, networking, and cybersecurity

  .
• Experience with

  GxP-compliant systems, 21 CFR Part 11, and data integrity requirements

  .
• Familiarity with

  SCADA, LIMS, Empower, and other lab automation systems

  .
• Strong understanding of

  pharmaceutical regulatory requirements (USFDA, EU GMP, MHRA, WHO, etc.)

  .
• Hands-on experience in

  IT validation, CSV (Computer System Validation), and audit management

  .
• Excellent

  leadership, communication, and problem-solving skills

  .

Language Proficiency:

• Good communication skills
• Familiar with

  Hindi

  ,

  Gujarati

   and

  English

Preferred Certifications:

• CISA / CISM / CISSP

   (for IT security & compliance).

• ITIL

• GAMP 5, 21 CFR Part 11, Data Integrity training

  .

Warm Regards,

Jolly Nayak

3POINTHRM