Validation Specialist/System Management Support

Vertragsart:
Vor Ort
Start:
01/01/2018
Dauer:
12 months
Von:
Harvey Nash IT Recruitment Switzerland
Ort:
Basel
Eingestellt:
06.10.2017
Land:
flag_no Schweiz
Projekt-ID:
1429050

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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.