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Job Details

Validation Specialist

Company: MSI Group Limited
Reference: VR7632
Closing Date: 05 Nov 17
Type: Contract
Salary (£): Competitive

Job Summary:

Contract - Basel - Validation


Our client are searching for a Validation Specialist who will be responsible for the communication and coordination of activities with system owners, QA and system users.  

Key Responsibilities:

  • GMP training according to clients quality system and training concept (including all relevant SOPs for analytical systems)
  • Authoring IQ and OQ test plans, PQ test plans, Q report 
  • Performing IQ13, IQ and OQ, OQ/PQ for verification of ERES
  • Supporting PQ  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 clients GMP document codes
  • Requests via IT ticketing tool
  • System administration for computerized systems and GMP
  • Non-GMP (DQP)

Skills Requirements:

  • Very good written and spoken English and German
  • 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
  • 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

GMP, IQ, OC, PQ Test Plans, Troubleshooting, GxP, 21 CFRPart11, Annex 11, German, GLIMS_IMA reports, Validation, Validation Specialist


Apply for this job: Validation Specialist

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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