CSV Business Analysts

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

For my Client a Medical Device Company based in Solothurn we are currently looking for several:

Business analysts with CSV

Start: 01.11.2014

Duration: 3 months+

Location: Zuchwil, Raron, Selzach or Waldenburg

Language: English and German

- Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants

- Work with and support the Business Owners with the business deliverables for Computer Systems Validation of GXP including not limited to:

* Requirements Identification and documentation

* System Test Scripting

* System Test Execution

* UAT Test Scripting

* Writing of Work Instructions/Procedures

- Work with IT and CSC in planning of validations of GXP systems.

- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

- Knowledge in technical skills like Technical Writing is requested

Requirements:

Higher education (Engineer or similar) and background in Computer System Validation and at least 5 years work experience

Responsibility in similar management position or extended experience as executer required. Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11

Familiarity with med. device manufacturing plants, SDLC

Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
ab sofort
Dauer
3 months
Von
Michael Bailey Associates - Zurich
Eingestellt
21.10.2014
Projekt-ID:
794579
Vertragsart
Freiberuflich
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