Computer System Validation (CSV)

Ics India; Aurangabad; On-site; INR 600,000 - 800,000; Full time

Benefits offered by this job

Competitive salary

PF/ESIC insurance

Medical insurance

Accidental insurance

Full time role

Job summary

Ics India is seeking a qualified validation professional for Computer System Validation (CSV) in QC environments, with expertise in IQ/OQ/PQ and equipment qualification. The role targets individuals with 2-5 years of relevant experience and a Diploma or BE/BTech in Instrumentation, Electrical, or Electronics.

The candidate will prepare URS, FS, DS, RTM and ensure compliance with 21 CFR Part 11 & GAMP 5 in on-site projects across Pune, Mandideep and Ahmedabad.

Qualifications

• Hands-on experience in Computer System Validation (CSV).
• Knowledge of Equipment Qualification (QA), HVAC.
• Strong knowledge of 21 CFR Part 11 & GAMP 5.
• Experience in IQ / OQ / PQ execution.
• Validation of systems & server-based applications.
• Preparation & review of documents: URS, FS, DS, RTM.
• Good understanding of compliance & documentation practices.
• Strong understanding of CSV lifecycle & regulatory expectations.

Skills

CSV validation in QC environments

Equipment Qualification (QA)

21 CFR Part 11 & GAMP 5

IQ/OQ/PQ execution

Validation of systems & server-based

URS/FS/DS/RTM documentation

Compliance & documentation practices

CSV lifecycle & regulatory

Education

Diploma/BE/BTech in Instrumentation or Electrical or Electronics

Job description

Location: Pune | Mandideep | Ahemdabad
Qualification: Diploma,B.E/B.Tech Instrumentation, Electrical, Electronics or equivalent
Experience: 2-5 Year

What We Offer:
- Competitive Salary as per industry standards
- PF, ESIC, Medical & Accidental insurance
- Full time role

Key skill requirements:
- Hands-on experience in Computer System Validation (CSV), CSV in QC (Quality Control) environments.
- Knowledge of Equipment Qualification (QA perspective),HVAC.
- Strong knowledge of 21 CFR Part 11 & GAMP 5.
- Experience in IQ / OQ / PQ execution.
- Validation of systems & server-based applications.
- Preparation & review of documents: URS, FS, DS, RTM.
- Good understanding of compliance & documentation practices.
- Strong understanding of CSV lifecycle & regulatory expectations.