Validation Expert / System Management Support / no-923

Status: 
closed
Location: 
4070 Basel (Klybeck)
Start Date: 
2018-09-01
End Date: 
2019-08-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
2.080
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) an  Validation Expert

  • Type of placement:  12 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area

 

Job Titel 

  • Validation Specialist / System Management Support - 100% work load

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 Novartis 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