It Executive

Stanford Laboratories; Una; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Stanford Laboratories is seeking an IT professional to lead Computer System Validation (CSV) for manufacturing systems, ensuring compliance with GxP and 21 CFR Part 11. You will develop, execute, and maintain validation protocols (IQ, OQ, PQ) and support audits.

You will collaborate with QA, QC, Production, and Engineering to strengthen data integrity, risk assessments, data security, and regulatory submissions, while coordinating with vendors for system upgrades and continuous improvement.

Qualifications

• Develop, execute, and maintain CSV validation protocols (IQ, OQ, PQ).
• Ensure regulatory compliance with FDA, EMA, and other guidelines.
• Maintain audit-ready documentation for inspections.
• Implement GxP IT controls and data integrity measures (ALCOA+).
• Support QA/QC, production, and engineering audits and risk assessments.
• Train plant staff on IT compliance and system usage.

Responsibilities

• Manage CSV validation activities for manufacturing IT systems.
• Oversee data integrity and 21 CFR Part 11 compliance.
• Coordinate with vendors for system upgrades and troubleshooting.
• Monitor cybersecurity measures and system performance.
• Collaborate with QA, QC, Production, and Engineering teams.
• Support regulatory submissions and audits.

Skills

CSV knowledge

GxP compliance

ERP/LIMS/MES familiarity

21 CFR Part 11 compliance

Cybersecurity measures

Audits & risk assessments

Tools

ERP systems

LIMS

MES

Job description

Role & responsibilities

• Computer System Validation (CSV)
  • Develop, execute, and maintain validation protocols (IQ, OQ, PQ).
  • Ensure compliance with FDA, EMA, and other regulatory guidelines.
  • Maintain documentation for audits and inspections.
• GxP Compliance
  • Implement and monitor IT systems in line with GxP requirements.
  • Support Quality Assurance in system audits and risk assessments.
  • Ensure data integrity and adherence to ALCOA+ principles.
• Pharma Manufacturing IT Systems
  • Manage ERP, LIMS, MES, and other plant-related applications.
  • Provide technical support for production and quality operations.
  • Coordinate with vendors for system upgrades and troubleshooting.
• Data Management
  • Oversee secure handling of electronic records and signatures (21 CFR Part 11).
  • Ensure backup, recovery, and disaster recovery protocols.
  • Monitor system performance and implement cybersecurity measures.
• Cross-functional Collaboration
  • Work closely with QA, QC, Production, and Engineering teams.
  • Support audits, inspections, and regulatory submissions.
  • Train plant staff on IT compliance and system usage.