Computer System Validation Expert

We are looking for a validation expert with expertise in laboratory and computer systems validation.
Tasks:

. Writing and reviewing SOP
. providing Input to change management electronic system for change requests. Creating GLIMS_IMA reports; data base for all analytical systems and their validation status
. Generation of GMP document codes
. Requests via IT ticketing tool

System administration for computerized systems
Administration of analytical software applications, User administration
. Creation of analytical templates/protocols
Troubleshooting, repairs, changes to analytical systems and system-specific data Servers
Initial qualifications, migrations; including all required documents
. Preparing qualification logbook, qualification plan, URS
. 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. Periodic requalification and functional checks

. Keeping system binder up to date
. management of data base for all analytical systems and their validation status. Coordination of external service and repairs
. Input for cost prediction and control

Requirement: Prior experience in computerized system validation, instrument or software validation within a pharmacetuical 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

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.