Role Description We are looking for an experienced Computerized System Validation (CSV) Specialist to support the validation, implementation, and lifecycle management of LIMS and QMS systems within a regulated GxP environment.
Key Responsibilities
Lead and execute CSV activities for LIMS, QMS, and other GxP computerized systems.
Develop and review validation documentation, including URS, Risk Assessments, Functional/Design Specifications, Traceability Matrices, Validation Plans, IQ/OQ/PQ protocols, and Validation Reports.
Perform GxP impact assessments and risk-based validation in accordance with GAMP 5 principles.
Support system implementation, configuration, testing, and release activities.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP, GMP, and Data Integrity/ALCOA+ requirements.
Manage validation lifecycle activities, including Change Controls, Deviations, CAPA, Periodic Reviews, and system retirement.
Collaborate with QA, IT, Laboratory, Manufacturing, Business Process Owners, and system vendors.
Support internal and external audits and regulatory inspections.




Ensure computerized systems remain in a validated state throughout their lifecycle.

Qualifications
Strong skills in Computer System Validation and Validation activities for GxP or laboratory environments.
Experience with Process Validation and understanding of end-to-end workflows in testing or manufacturing.
Proficiency in Quality Control practices and familiarity with analytical or laboratory processes.
Knowledge of Quality Assurance principles, documentation standards, and regulatory compliance.
Ability to interpret and apply relevant regulations and guidelines (e.g., FDA, Health Canada, EU, GAMP, ISO).
Experience creating and maintaining validation documentation, including URS, FS, DS, IQ/OQ/PQ, and risk assessments.
Solid analytical, problem-solving, and troubleshooting skills with attention to detail and data integrity.
Effective communication and collaboration skills, with the ability t

📌 Computerized System Validation (Bengaluru)
🏢 Pathogenia Lab
📍 Bengaluru