Bachelor's degree in a related field, 2-5 years of CSV experience, Familiarity with regulatory guidelines, Experience with validation software tools.
Key responsabilities:
Manage and execute Computer System Validation projects
Prepare and review validation documentation and reports
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Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing