Validation Specialist/System Management Support

Vertragsart:
Vor Ort
Start:
keine Angabe
Dauer:
keine Angabe
Von:
Harvey Nash IT Recruitment Switzerland
Ort:
Basel
Eingestellt:
01.08.2018
Land:
flag_no Schweiz
Projekt-ID:
1607696

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For our client in Basel we are looking for a Validation Specialist/System Management Support (100%) for a 12-month contract.

Period: to
Location: Basel
Workload: 100%

Purpose of the position:
Communication and coordination of activities with system owners, QA and system users
Tasks & Responsibilities: 
. GMP training according to company quality system and training concept (SOP)
. Analogous DQP training for pre-defined systems
. HSE training
. Writing SOPs E-SOPs
. Input change management in TQW (= electronic system for change requests)
. Creating GLIMS_IMA reports; editing of GLIMS_IMA
. Generation of company GMP document codes
. Requests via IT ticketing tool
- System administration for computerized systems
. GMP and Non-GMP (DQP)
. Data administration
. Preparing qualification logbook, qualification plan, URS
. Authoring IQ13 documents, OQ/PQ for verification of ERES
. Authoring IQ and OQ test plans, PQ test plans, Q report
. Performing IQ13, IQ and OQ, OQ/PQ for verification of ERES
. Supporting PQ
. Alignment with SO, QA and instrument users
. Periodic requalification and functional checks
. GLIMS_IMA (= data base for all analytical systems and their validation status)
. Coordination of external service and repairs
. Input for cost prediction and control

Must Haves:
. 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
. Fluent English and German

Are you available immediately, have experience working in IT Validation and IT System Management Support?
Please send your complete CV to (see below) For further details feel free to call me. I am looking forward to receiving your application.