Qualifica,on : B Pharm / M Pharm

Experience : Freshers

Location : Client Sites in India

Industry : IT Services / Validation Consuling / Life Sciences

Role Summary

We are looking for a Computer System Valida,on Engineer to support multiple life sciences clients in

a service/consul9ng environment. The role involves hands-on execution of CSV activities, client

interaction, and audit support for GxP-regulated systems.

Key Job Responsibili,es

- Execute CSV actvites as per GAMP 5, 21 CFR Part 11, and EU Annex 11
- Prepare and execute valida9on deliverables:

o Validaton Plan / VMP sections

o URS, FS, DS

o Risk Assessments (FMEA / Risk-based)

o IQ, OQ, PQ protocols and reports

- Validate systems such as PLC, Lab Computerized Systems, LIMS, QMS, DMS, ERP, SAP, SaaS

and custom applica9ons

- Execute test scripts, collect evidence, and maintain traceability
- Work on multiple client projects simultaneously and meet delivery timelines
- Support internal, client, and regulatory audits (USFDA, EMA, MHRA,



WHO, PIC/s
- Participate in client meetings and audit discussions, including global time zones if required

Required Skills & Experience

- Understanding of QA / Validation Practices
- Positive documentation and communication skills
- Comfortable with client-facing and audit-facing roles

Good to Have

- Knowledge of:

o GAMP 5

o US FDA 21 CFR Part 11

o EU Annex 11

o SDLC / Agile valida9on concepts

- Data Integrity (ALCOA+) knowledge
- Good Communication and writing Skills preferably in English

What We Expect

- Strong ownership and accountability
- Ability to work independently with minimal supervision after due Training
- Flexibility during audits and critical project phases
- Professional conduct with clients and QA team

Benefits:

- Paid sick time
- Paid time off

Work Location: In person

📌 Validation Engineer (Ahmedabad)
🏢 Anthem Gxp solutions Private
📍 Ahmedabad