System Management Support - GMP - Quality - Switzerland - Contract

Basel-Stadt  ‐ Vor Ort
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Beschreibung

System Management Support required, to work on a project within a major pharmaceutical company in Switzerland.
Period: to

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

  • 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 ESOPS
  • Input change management in TQW
  • Creating GLIMS_IMA reports; editing of GLIMS_IMA entries
  • Generation of GMP document codes
  • Requests via I.MAN

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
    Evaluation of new analytical system software for compliance to SOPs Initial qualifications, migrations; including all required documents
  • Preparing qualification logbook, qualification plan, URS
  • Authoring IQ13 documents, OQ/PQ for verification of ERES
  • Authoring IQ and OQ test plans, PQ test plans, Q report
  • Performing IQ13, IQ and OQ, OQ/PQ for verification of ERES
  • Supporting PQ
  • Supporting retirement of laboratory systems
  • Performing periodic system reviews
  • 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
  • Coordination of external service and repairs
  • Input for cost prediction and control

Are you interested to work in this challenging position? Robert Stanislawek, is looking forward to receiving your complete profile.

Start
1. July 2016
Dauer
4months+
(Verlängerung möglich)
Von
Coopers Group GmbH
Eingestellt
12.05.2016
Projekt-ID:
1127721
Vertragsart
Freiberuflich
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