Computer System Validation Specialist

Avon Quality Management; Delhi; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Avon Quality Management is seeking a skilled CSV Specialist to validate QMS software for life sciences clients. You will lead validation activities, develop critical documentation, and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

You will conduct risk assessments, advise on data integrity, and train client teams while creating SOPs for sustained compliant use of validated systems. Strong communication and project management skills are essential.

Formación

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field; Master’s is a plus.
• Minimum 2 years’ experience in CSV within life sciences.
• Experience with QMS software implementation is highly desirable.
• Familiarity with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 or ISO 13485.

Responsabilidades

• Lead client validation of QMS software including planning, execution, and documentation.
• Develop and review validation deliverables (VP, URS, FRS, RTM, IQ/OQ/PQ, VR).
• Guide clients on regulatory standards and risk-based validation approaches.
• Provide risk management and data integrity recommendations.
• Train client teams and develop SOPs for ongoing compliance.

Conocimientos

QMS validation

Regulatory compliance

Documentation

MS Office

Educación

Bachelor's degree in Life Sciences/Engineering/CS

Herramientas

ETQ Reliance

MasterControl

Veeva Vault QualityDocs/Quality Suite

TrackWise Digital

Descripción del empleo

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.

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.