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Validation Specialist / System Management SupportRef: mc 23529


Added:08 Aug 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical IT

Tasks: * GMP training according to Novartis quality system and training concept (including all relevant SOPs for analytical systems) * Analogous DQP training for pre-defined systems * HSE training (including BL2) * Writing SOPs E-SOPs * Input change management in TQW (= electronic system for change requests) * Creating GLIMS_IMA reports; editing of GLIMS_IMA entries (= data base for all analytical systems and their validation status) * Generation of Novartis GMP document codes * Requests via IT ticketing tool - System administration for computerized systems * GMP * Non-GMP (DQP) - Admin for analytical software applications * User administration * Creation of analytical templates / protocols * Data administration - Troubleshooting, repairs, changes to analytical systems and system-specific data servers - Initial qualifications, migrations; including all required documents * Preparing qualification logbook, qualification plan, URS (= User requirements) * Authoring IQ13 documents, OQ/PQ for verification of ERES (=Electronic Record and Electronic Signature) * Authoring IQ and OQ test plans, PQ test plans, Q report * Performing IQ13, IQ and OQ, OQ/PQ for verification of ERES * Supporting PQ - Full system responsibility of pre-defined systems (role of the instrument responsible person) * Alignment with SO, QA and instrument users * Periodic requalification and functional checks * Keeping system binder up to date * GLIMS_IMA (= data base for all analytical systems and their validation status) * Coordination of external service and repairs * Input for cost prediction and control Candidate Profile: * At least 3 years experience in computerized system validation, instrument or software validation or related area within a regulated industry * General knowledge of GxP, 21CFRPart11, Annex 11, or knowledge in other quality systems * Good communication skills, very good written and spoken English and German

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