Job Description

Role & responsibilities: - Responsible for Computer System Validation (CSV) of laboratory instruments and computerized systems in compliance with GxP, 21 CFR Part 11, and EU Annex 11 regulations. - Lead CSV activities for lab systems (HPLC, GC, TOC, LIMS, CDS, ELN, Empower). - Prepare validation documents: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, Summary Reports. - Ensure compliance with data integrity (ALCOA+) and Part 11 electronic records/e-signature r requirements. - Collaborate with QA, IT, and vendors for validation planning and execution. - Support system change controls, re-validation, and periodic reviews. - Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11. - Experience with lab systems/software validation. - Excellent documentation and communication skills.