System Management Support - GMP - Quality - Switzerland - Contract

SYSTEM MANAGEMENT SUPPORT required, to work on a project within a major pharmaceutical company in Switzerland.

Period: 01/07/2016 to 31/10/2016

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.