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 setting.

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.
- Strong analytical, problem-solving, and troubleshooting skills with attention to detail and data integrity.
- Effective communication and collaboration skills, with the ability to work cross-functionally in a laboratory setting.
- Post-secondary degree or diploma in a scientific, engineering, or technical discipline (e.g., microbiology, chemistry, computer science, engineering) or equivalent experience.
- Prior experience in food safety, pharmaceutical, biotechnology, or regulated laboratory environments is an asset.

📌 Computerized System Validation (CSV) Specialist | LIMS & QMS (Bengaluru)
🏢 Pathogenia Lab
📍 Bengaluru