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Validation Specialist/System Management Support
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support
Projektbeschreibung
Harvey Nash is looking for a Validation Specialist/System Management Support for a 12-month-project in Switzerland.
The role is for communication and coordination of activities with system owners, QA and system users.
You are responsible for
* GMP training according to clients' 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 E-SOPs
* Input change management in TQW (= electronic system for change requests)
* Creating GLIMS_IMA reports; editing of GLIMS_IMA entries (= data base for all analytical systems and their validation status)
* Generation of clients' GMP document codes
* Requests via IT ticketing tool
* System administration for computerized systems
* Administration for analytical software applications
* Troubleshooting, repairs, changes to analytical systems and system-specific data Servers
* Initial qualifications, migrations; including all required documents
Requirements
* At least 3 years' experience in computerized system validation, instrument or software validation or related area within a regulated 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
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
The role is for communication and coordination of activities with system owners, QA and system users.
You are responsible for
* GMP training according to clients' 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 E-SOPs
* Input change management in TQW (= electronic system for change requests)
* Creating GLIMS_IMA reports; editing of GLIMS_IMA entries (= data base for all analytical systems and their validation status)
* Generation of clients' GMP document codes
* Requests via IT ticketing tool
* System administration for computerized systems
* Administration for analytical software applications
* Troubleshooting, repairs, changes to analytical systems and system-specific data Servers
* Initial qualifications, migrations; including all required documents
Requirements
* At least 3 years' experience in computerized system validation, instrument or software validation or related area within a regulated 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
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges