The CSV Specialist will be responsible for the validation and lifecycle management of GxP computerized systems used across pharmaceutical operations. The role involves preparation, review, execution, and maintenance of Computer System Validation (CSV) documentation to ensure systems are fit for intended use and compliant with applicable regulatory and data integrity requirements.

Key Responsibilities
- Perform Computer System Validation (CSV) activities for GxP-regulated computerized systems.
- Prepare, review, and execute validation documentation, including:
- Validation Plan (VP)
- User Requirement Specification (URS)
- Functional/Design Specifications (FS/DS)
- Risk Assessment (RA)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirement Traceability Matrix (RTM)
- Validation Summary Report (VSR)
- Ensure computerized systems comply with applicable requirements and guidelines, including GxP, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and Data Integrity principles.




- Perform risk-based assessment of computerized systems and determine appropriate validation requirements.
- Review and assess system functionalities, electronic records, electronic signatures, audit trails, user access controls, backup and restoration, and security controls.
- Support validation and qualification of systems such as LIMS, ERP/SAP, DMS/EDMS, QMS, laboratory software, manufacturing systems, and other GxP applications.
- Manage CSV activities throughout the system lifecycle, including implementation, operation, change control, periodic review, upgrades, and retirement.
- Review and approve change controls, deviations, incidents, CAPA, and validation-related documents.
- Perform periodic reviews and ensure validated systems remain in a compliant state.
- Coordinate with QA, IT, Engineering, QC, Manufacturing, vendors, and other cross-functional teams for CSV activities.
- Support data integrity assessments and ensure compliance with AL

📌 CSV Specialist (Hyderabad)
🏢 Ritsa Pharma
📍 Hyderabad