10 days ago on simplyvision.ch

Validation Expert

SimplyVision GmbH

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 Please refer to JobSuchmaschine in your application

Validation Expert

Status: 
active
Location: 
4070 Basel
Start Date: 
2018-01-01
End Date: 
2018-12-31
Deadline: 
2017-11-03 10:25
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
2.088
Assignment: 
Background

For our Swiss customer located in Basel we are currently looking for (m/f) an Validation Specialist / System Management Support 

 

Purpose of the position 
  • Communication and coordination of activities with system owners, QA and system users 

     
Tasks
  • GMP training according to 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 
Requirements: 
  • 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