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Job Post Details
Junior Computer System Validation (CSV) Specialist
Junior Computer System Validation (CSV) Specialist
Job details
Full job description
We are expanding our team!If you are passionate about quality, compliance, and the intersection of technology and pharma, this is your chance to kickstart your career. Eiffel Life Sciences is looking for a detail-oriented Junior CSV Specialist to join our team in Bengaluru! If you have a solid foundation in GxP and are eager to dive into modern validation and assurance practices, we want to hear from you.
Job Title: Junior Computer System Validation (CSV) Specialist
Company: Eiffel Life Sciences
Location: Bangalore, Karnataka (Hybrid) Employment Type: Full-Time
About the Role: As a Junior CSV Specialist, you will support the validation lifecycle of critical computerized systems used in the pharmaceutical and life sciences industries. You will work closely with our senior consultants and QA teams to ensure that all software and IT infrastructure comply with global regulatory standards (FDA, EMA) while helping us champion modern Computer Software Assurance (CSA) methodologies.
Key Responsibilities: Assist in drafting, reviewing, and executing validation deliverables (Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Summary Reports). Execute test scripts and meticulously document results, identifying and reporting any defects or deviations.
Computer Software Assurance (CSA) approaches. Collaborate with cross-functional teams (IT, QA, and Engineering) to ensure GxP systems maintain their validated state. Help maintain the traceability matrix and ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
What We're Looking For:
Education: Bachelor's degree in Pharmacy, Computer Science, Engineering, or a related Life Sciences field.
Experience: 0-2 years of experience (or relevant internships) in the pharmaceutical, medical device, or biotechnology industry.
Knowledge: Basic understanding of GAMP 5, GxP regulations, and system development life cycle (SDLC) methodologies.
Skills: Excellent technical writing and documentation skills. A keen eye for detail is an absolute must!
Mindset: A proactive learner who is ready to absorb new concepts in regulatory compliance and digital transformation.
Why Join Us? Hands-on mentorship from industry experts. Exposure to global pharmaceutical projects and next-gen validation technologies. A collaborative and fast-paced startup environment where your voice matters.
How to Apply: Ready to ensure quality in digital health? Send your resume to mail@eiffellifesciences.com with the subject line "Junior CSV Specialist - Bangalore' or simply apply through the link below!
eiffellifesciences.com
https://www.linkedin.com/company/eiffel-life-sciences
Pay: From ₹50,000.00 per month
Benefits:
- Flexible schedule
- Food provided
Work Location: In person