System Management Support (Between 80 and 100%)

Harvey Nash is looking for Support for System Management for a 6 month project in Switzerland.

The role is for communication and coordination of activities with system owners, QA and system users.

You are responsible for

* GMP training according to Novartis 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 Novartis 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 available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.