CSV (Computer System Validation)
We are seeking an experienced Computer System Validation (CSV) Specialist to lead and support the validation of GxP-compliant systems used in manufacturing, laboratories, and quality assurance functions. The ideal candidate will possess strong domain knowledge in pharma operations, validation methodologies, and regulatory compliance, along with hands-on experience in validating systems like TrackWise, SAP, SCADA , and MES . Key Responsibilities: Develop and execute CSV lifecycle documentation : URS, Risk Assessment, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports. Ensure compliance with 21 CFR Part 11 , Annex 11 , GAMP 5 , and GxP guidelines. Manage validation of GxP-critical systems including LIMS, QMS, ERP, PLC/SCADA , and electronic batch record (EBR) platforms. Collaborate with cross-functional teams (QA, IT, Manufacturing, Lab) for smooth implementation and validation of computerized systems. Review and approve vendor-supplied documentation and software qualification deliverables. Participate in audits and inspections; ensure readiness of CSV documentation and responses to regulatory bodies. Maintain Change Control and Periodic Review activities for validated systems. Provide training to stakeholders on system validation procedures and compliance expectations. Required Qualifications: B.Pharm from a recognized university (M.Pharm or additional certifications in CSV is a plus). 5–8 years of relevant experience in Computer System Validation in a regulated pharmaceutical or life sciences environment. Strong working knowledge of LIMS , TrackWise , SAP , MES , or other pharma-grade software systems. Familiarity with data integrity principles , GAMP 5 guidelines, and risk-based validation approaches (CSA exposure is a plus). Good documentation practices and ability to work across cross-functional teams. Key Skills & Competencies: Expertise in CSV lifecycle and compliance frameworks Strong understanding of pharma shop floor and laboratory processes Risk assessment & validation planning Cross-functional communication and stakeholder management Audit preparedness and regulatory interaction experience
