IT Manager

Job Title: IT Manager Infrastructure, Networking & GxP Systems

Location: Sarigam. Vapi. Gujarat

Department: Information Technology

Job Summary:

We are seeking an experienced IT Manager to lead the IT infrastructure, networking, and production/QC instrumentation functions within our pharmaceutical manufacturing facility. The ideal candidate will be responsible for ensuring compliance with USFDA, GxP, CFR Part 11, and other regulatory IT requirements, while managing IT operations to support manufacturing and quality control. Should have faced various audits like USFDA,  European Audits, Other audits etc.,

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