Validation Expert (no-368)

Status: 
active
Location: 
4070 Basel
Start Date: 
2018-01-01
End Date: 
2018-12-31
Deadline: 
2017-10-11 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

CV-Template

Use the chance to make your CV specific for each job posting. Make sure you have all the keywords in it they like to have and you can provide. In any case give a statement to each requirement.

JobPosting Application

Personal information
Please copy and give us a short statement on each requirement, as is required in our CV template. If you use your own CV please insert it in the upper part. Put all the keywords of the job posting, you can provide, at a prominent place in your CV, especially the project list. It will give you a much better chance!
Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
Work Permit
If not - no problem - we'll organize one.
Recommendation