Computer System Validation Expert

Switzerland  ‐ Onsite
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Description

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.
Start date
09/2018
Duration
12 months
From
Michael Bailey Associates
Published at
02.08.2018
Project ID:
1608296
Contract type
Freelance
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