01
TRCD-26-05222
CSV Consultant (Computer System Validation)
Hire a CSV (Computer System Validation) Consultant with 3–4 years’ hands-on experience to execute end-to-end CSV lifecycle activities for pharma/life sciences clients. The role covers authoring/reviewing validation deliverables (VP, URS/FRS/DS, RA/RTM, IQ/OQ/PQ, VSR), performing GxP assessments and 21 CFR Part 11 / EU Annex 11 evaluations, applying GAMP 5 risk-based validation, supporting change/deviation/CAPA impact assessments, ensuring ALCOA+ data integrity, executing test scripts, and supporting audits/inspections while coordinating with QA, IT, business users, engineering, and vendors.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Contract
- Experience
- Minimum 3 years and Maximum 4 years
Role overview
Why This Role Matters.
Hire a CSV (Computer System Validation) Consultant with 3–4 years’ hands-on experience to execute end-to-end CSV lifecycle activities for pharma/life sciences clients. The role covers authoring/reviewing validation deliverables (VP, URS/FRS/DS, RA/RTM, IQ/OQ/PQ, VSR), performing GxP assessments and 21 CFR Part 11 / EU Annex 11 evaluations, applying GAMP 5 risk-based validation, supporting change/deviation/CAPA impact assessments, ensuring ALCOA+ data integrity, executing test scripts, and supporting audits/inspections while coordinating with QA, IT, business users, engineering, and vendors.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
02
Validation Plan (VP)
03
User Requirement Specification (URS)
04
Functional Requirement Specification (FRS) & Design Specification (DS)
05
Risk Assessment (RA) & Traceability Matrix (RTM)
06
Qualification Protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
07
Validation Summary Report (VSR)
08
Regulatory Compliance & Assessments: Perform GxP assessments, evaluate automated systems for regulatory compliance, and conduct rigorous 21 CFR Part 11 and EU Annex 11 evaluations.
09
Risk-Based Approach: Participate in risk-based validation strategies following GAMP 5 guidelines.
10
Change & Incident Management: Review system changes, deviations, incidents, CAPAs, and change controls to evaluate potential validation impacts.
11
Cross-Functional Collaboration: Coordinate seamlessly with Quality Assurance, IT, Business Users, Engineering, and Vendors throughout validation lifecycles.
12
Audits & Inspections: Provide active support during internal and external audits, client inspections, and regulatory assessments.
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
01
CSV
Required
02
Computer System Validation
Required
03
IT Compliance
Required
04
GxP
Required
05
GAMP 5
Required
06
21 CFR Part 11
Required
07
EU Annex 11
Required
08
ALCOA+
Required
09
Data Integrity
Required
10
Validation Plan
Required
11
VP
Required
12
URS
Required
13
FRS
Required
14
Design Specification
Required
15
DS
Required
16
Risk Assessment
Required
17
RA
Required
18
Traceability Matrix
Required
19
RTM
Required
20
IQ
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
Computer System Validation (CSV) end-to-end lifecycle execution
Validation documentation authoring/review: VP, URS, FRS, DS, RA, RTM, IQ, OQ, PQ, VSR
GxP compliance and assessments
21 CFR Part 11 compliance evaluation
EU Annex 11 compliance evaluation
GAMP 5 risk-based validation approach
Data integrity principles (ALCOA+)
Change control / change management validation impact assessment
Deviation/incident/CAPA review for validation impact
Test script execution and compliance documentation
Audit/inspection support (internal/external/regulatory)
Cross-functional stakeholder coordination (QA, IT, business users, engineering, vendors)
Strong written and verbal communication
Structured, analytical mindset
Preferred
Nice to Have
Risk Consulting experience
Experience working in consulting/client environments
Experience across multiple client systems/environments
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for CSV Consultant (Computer System Validation)
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