Computer System Validation Expert

Salaris Omschrijving:
Job Ref:

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

• 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.

Tel: 020 7739 2022
Contact: Beata Klecz

u kunt teruggaan naar uw huidige zoekresultaten door te klikken op.

Latest Job Listings