IT Quality Assurance (QA) & Computer System Validation (CSV)

RK Hr Management; Ahmedabad District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

RK Hr Management seeks a Lead CSV & IT QA for pharma manufacturing in India to ensure GxP compliance, ERP validation, and data integrity across the system lifecycle.

The role requires 6–10 years in Pharma QA/CSV, with hands-on experience in LIMS, MES, SCADA, and greenfield sites, plus knowledge of GAMP 5, 21 CFR Part 11 and Annex 11. You will lead audits and drive rigorous change control to sustain validated operations.

Qualifications

• 6–10 years in Pharma QA/CSV
• GAMP 5, 21 CFR Part 11, Annex 11
• Experience with LIMS, MES, SCADA, and greenfield sites

Responsibilities

• Lead CSV & IT QA for pharma manufacturing.
• Ensure GxP compliance across systems and processes.
• Manage ERP validation, data integrity, and audit trails.
• Oversee change control, SOPs, and supplier oversight during validated lifecycle.
• Coordinate regulatory audits and vendor qualifications.

Skills

QA/CSV

GxP compliance

ERP validation

Data integrity

Audit trails

Change control

SOPs

Regulatory audits

Education

Bachelor’s in Pharmacy/IT/CS

Tools

LIMS

MES

SCADA

ERP systems

Job description

Lead CSV & IT QA for pharma manufacturing, ensuring GxP compliance, ERP validation, data integrity, audit trails, risk management, change control, SOPs, supplier oversight, regulatory audits, and validated system lifecycle.

Required Candidate profile

Bachelor’s in Pharmacy/IT/CS with 6–10 years in Pharma QA/CSV, ERP validation, and data integrity. GAMP 5, 21 CFR Part 11, Annex 11; experience with LIMS, MES, SCADA, and greenfield sites.