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Job Details

Validation Specialist / System Management Support

Company: Hobson Prior
Location: Switzerland
Reference: OG
Closing Date: 10 Sep 18
Type: Contract
Salary (£): On Application
Benefits: 70-100 CHF / hour

Job Summary:

Communication and coordination of activities with system owners, QA and system users

Requirements:

Tasks: 

  • GMP training according to the client's 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 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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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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