Talent.com
avon quality management
Computer System Validation Specialistavon quality management • Delhi, Bawana, India
Computer System Validation Specialist

Computer System Validation Specialist

avon quality management • Delhi, Bawana, India
30+ days ago
Job description
We are looking for a skilled Computer System Validation (CSV) Specialist to join our team. In this role, you will focus on assisting our clients in validating quality management system (QMS) software within the life sciences industry. You will ensure that the QMS software solutions meet regulatory requirements and industry standards, supporting our clients in achieving compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other applicable regulations.

This is a client-facing role that requires strong technical expertise, regulatory knowledge, and excellent communication skills.

The Core Responsibilities For The Job Include The Following

System Validation Support for Clients:

  • Lead the validation of QMS software for clients, including planning, execution, and documentation of validation activities.
  • Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR).
  • Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11 EU Annex 11 and GAMP 5

Risk Management And Data Integrity

  • Conduct risk assessments for computerized systems to identify potential gaps in compliance.
  • Provide recommendations for mitigating risks related to data integrity, security, and system functionality.

Client Training And Documentation

  • Trained client teams on validation processes, regulatory requirements, and best practices for maintaining validated systems.
  • Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance.

Regulatory Expertise

  • Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts.
  • Guided data integrity principles and ensured alignment with industry standards.

Requirements

  • Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field. A Master's degree is a plus.
  • Minimum of 2 years of experience in computer system validation within the life sciences industry.
  • Experience with QMS software implementation is highly desirable.
  • Proven track record of working with regulatory frameworks such as FDA 21 CFR Part 11 EU Annex 1,1 GAMP 5 or ISO 13485

Technical Skills

  • Strong understanding of validation methodologies and documentation requirements for computerized systems.
  • Familiarity with leading QMS software platforms such as ETQ Reliance, MasterControl, Veeva Vault QualityDocs/Quality Suite, TrackWise Digital, or similar tools is a plus.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and project management tools.

Soft Skills

  • Excellent written and verbal communication skills to interact effectively with clients at all levels of an organization.
  • Strong problem-solving skills with the ability to manage multiple projects simultaneously under tight deadlines.

This job was posted by Saurabh Jain from Avon Quality Management.
Skills Required
Computer System Validation, Iso 13485, data integrity, Risk Management
Create a job alert for this search

Computer System Validation Specialist • Delhi, Bawana, India

Similar jobs

Food & Beverage Server (Full-Time/Part-Time)

StoneX GlobalDelhi, Republic Of India, IN

In recent years, StoneX has forayed into an art-driven luxury lifestyle brand, focused on delivering enriching experiences.Challenging conventions, it merges artistic expression with exceptional cr... Show more

 • Promoted

Field Services Engineer

CATLDelhi, Republic Of India, IN

CATL invites you to continue our legend of green energy!.CATL is a World Fortune 300 Company, a global leader who provides premier EV battery and energy storage battery for the world.CATL's EV batt... Show more

 • Promoted

Business Compliance Manager (Control Remediation)

RevolutDelhi, Republic Of India, IN

People deserve more from their money.More visibility, more control, and more freedom.Since 2015, Revolut has been on a mission to deliver just that.Our powerhouse of products — including spending, ... Show more

 • Promoted

Research And Development Specialist

GNT Page Private LimitedDelhi, Republic Of India, IN

HiringAlert | Senior Research Scientist / Team Leader – Formulation R&D (FR&D).We are looking for an experienced and technically strong.Senior Research Scientist / Team Leader – Formulation R&D (FR... Show more

 • Promoted

Analyst - Collections Analytics

bluCognitionDelhi, Republic Of India, IN

Cognition is an AI-powered commercial credit intelligence company serving lenders and financial institutions.Our platform combines commercial credit data contributed by 150+ lenders with AI-driven ... Show more

 • Promoted

Cerner Support Analyst

LuxoftDelhi, Republic Of India, IN

Support clients in the operation, maintenance, and optimization of Oracle Cerner EHR environments.This role is designed for early-career professionals who are eager to grow their technical skills i... Show more

 • Promoted

Sales Operations Specialist

PomeroyDelhi, Republic Of India, IN

Strong understanding of end‑to‑end sales processes, pipeline management, forecasting, quota/territory planning, and bookings/revenue metrics.Exceptional analytical skills combined with sound busine... Show more

 • Promoted

Electric Wiring Harness (Ewh) Engineer - Data Librarian

CabletequeDelhi, Republic Of India, IN

Cableteque comprises an international team with expertise in wire interconnects, CAD deployments, data exchange protocols, and AI.Our team is located worldwide, including the US, India, & Europe.Th... Show more

 • Promoted

Subject Matter Expert (Sme) - Information Technology

LearningMateDelhi, Republic Of India, IN

Job Title: Subject Matter Expert (SME) - Information Technology.Bachelor's/Master's in Computer Science, Information Technology, Software Engineering, Computer Engineering, or related field.Knowled... Show more

 • Promoted

Dental Claims Specialist

iCoreDelhi, Republic Of India, IN

If you are proactive, exceptionally organized, and take true pride in delivering measurable results, this is your opportunity to become the driving force behind iCore’s continued growth and success... Show more

 • Promoted

Senior Consultant

Atidan TechnologiesDelhi, Republic Of India, IN

Power Platform (admin + delivery);.CoE governance experience in large enterprises (10K+ users).Hands-on CoE Starter Kit implementation and operations (install, configure, troubleshoot, upgrade).Str... Show more

 • Promoted

Technical Associate (Remote, 6 Days/Week)

Xponentium IndiaDelhi, Republic Of India, IN
Remote

We will consider only those applicants who have filled the following google form: https://forms.Compensation: 15,000 INR/month fixed + 3,000 INR/month performance incentive (some flexibility for ca... Show more

 • Promoted

Client Implementation - Technical Support

AlgoworksDelhi, Republic Of India, IN

Role: Client Implementation Technical Support.Job timing - 12:30 PM to 11:30 PM.Algoworks is an award-winning artificial intelligence, engineering services and experience transformation firm with o... Show more

 • Promoted

Faculty - Computer Science

Westford Global EducationDelhi, Republic Of India, IN

Westford Global Education, established in 2009 and headquartered in the Isle of Man, delivers flexible, internationally recognized education across the Middle East, Europe, South Asia, Southeast As... Show more

 • Promoted

Call Center Representative

Miracle DrinksNorth, Delhi (union territory), IN

Miracle Drinks is a healthcare brand specializing in 100% herbal Neo Ayurveda protocols that support cellular regeneration and holistic well-being, addressing 170+ chronic conditions.Built on 35+ y... Show more

 • Promoted

Geographic Information System Developer

People Tech Group IncDelhi, Republic Of India, IN

Geographic Information System (GIS) applications.The ideal candidate should have hands-on experience with.GIS development, and geospatial data processing.The candidate will work closely with busine... Show more

 • Promoted

Customer Support Analyst - 1

BrightEdgeDelhi, Republic Of India, IN

About the Company Brightedge is a leader in enterprise SEO and content marketing technology, empowering global brands to optimize their digital presence and drive measurable business results.Our pl... Show more

 • Promoted

Senior IT Engineer

BOLTIndia, Delhi, IN

In this role, you'll be a cornerstone of our IT operations, acting as the second line of support for complex technical issues and taking ownership of our core IT systems.We're seeking an engineer w... Show more