Beschreibung
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.