Assistant Manager / Dy Manager - IT

Valence Labs; Patiala District, Zirakpur, Rajpura; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Valence Labs in India seeks an experienced IT Infrastructure and Compliance Lead to manage servers, networks, and security, ensuring high availability and data integrity across GxP systems.

You will lead CSV activities, ensure compliance with FDA 21 CFR Part 11 and GAMP 5, coordinate audits, and partner with QA and vendors to uphold validation standards.

The role requires a Bachelors in IT/CS, strong knowledge of CSV, IT governance, and incident response, with pharma exposure preferred.

Qualifications

• Experience in IT infrastructure management and CSV in a pharmaceutical or GxP-regulated environment.
• Knowledge of networking, servers, cybersecurity, backup, and DR.
• Hands-on expertise in GAMP 5, 21 CFR Part 11, data integrity, validation documentation, and audit support.

Responsibilities

• Manage servers, virtualization, storage, networks, firewalls, Wi‑Fi, and endpoint systems.
• Administer Windows servers, Active Directory, DNS, DHCP, user access, and cloud applications.
• Ensure system availability, performance, cybersecurity, backup, and disaster recovery.
• Manage IT helpdesk, incident resolution, change management, and end‑user support.
• Coordinate IT projects, vendor management, infrastructure upgrades, and asset lifecycle management.

Skills

IT infrastructure management

CSV in pharma

GxP/regulatory awareness

Education

Bachelor's degree in IT/CS

Tools

Active Directory

DNS/DHCP

GAMP 5

21 CFR Part 11

Job description

Role & responsibilities

A. IT Infrastructure & Operations

• Manage servers, virtualization, storage, networks, firewalls, Wi‑Fi, and endpoint systems.
• Administer Windows servers, Active Directory, DNS, DHCP, user access, and cloud applications.
• Ensure system availability, performance, cybersecurity, backup, and disaster recovery.
• Manage IT helpdesk, incident resolution, change management, and end‑user support.
• Coordinate IT projects, vendor management, infrastructure upgrades, and asset lifecycle management.

B. Computerized System Validation (CSV) & Compliance

• Lead CSV activities for GxP systems, including ERP, LIMS, QMS, and other regulated applications, as applicable.
• Prepare and maintain URS, risk assessments, validation protocols, IQ/OQ/PQ, traceability matrices, and validation reports, as applicable.
• Ensure computerized systems remain validated and in a state of control throughout their lifecycle.
• Ensure compliance with FDA 21 CFR Part 11, GAMP 5, data integrity, and applicable GxP requirements.
• Coordinate with QA, system owners, process owners, and vendors for validation, change control, deviations, and CAPA.
• Support internal audits, customer audits, and regulatory inspections by maintaining validation and IT compliance records.

C. Information Security & Governance

• Implement access controls, user account reviews, vulnerability management, and information security practices.
• Ensure backup restoration testing, business continuity, and disaster recovery readiness.
• Develop and maintain IT SOPs, technical documentation, asset records, and vendor qualification documents.
• Conduct periodic reviews of computerized systems and ensure timely closure of compliance gaps.

Preferred candidate profile

Bachelors degree in IT, Computer Science, or a related discipline.

• Experience in IT infrastructure management and CSV in a pharmaceutical or GxP-regulated environment.
• Knowledge of networking, servers, cybersecurity, backup, and disaster recovery.
• Hands‑on expertise in GAMP 5, 21 CFR Part 11, data integrity, validation documentation, and audit support.