Qualification & Validation Engineer

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Schlagworte

Beschreibung

Qualification & Validation Engineer

One of our best clients, a global multinational pharmaceutical company based in the Lugano area, is currently looking for a Qualification & Validation Engineer to join them on a long term basis.

Working language: Italian and English
Start date: Asap - within one month from offer

THE ROLE
*Provide support for the validation activities associated with equipment and business applications ensuring that all compliance issues and requirements of our client's Validation Policies and Procedures are addressed
*Serve as technical expert for the Validation process and responsibilities to ensure compliance
*Continuous Learning/Managing Risk
*Resolve & manage technical operational problems in area of expertise
*Suggest and sometimes may implement innovation and continuous improvement within the Validation process
*Implement initiatives in the Validation Process that will deliver customer value at lowest cost
*Facilitate successful team behaviour within Quality Systems and across functional areas
*Create Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise

YOUR PROFILE
*Process knowledge and documentation.
*In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
*High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
*Working experience of validation computer systems for use in a FDA regulated environment.
*Fluent English & Italian

If it sounds like your next challenge, send us your CV and we will call you shortly to discuss it further.

Start
ab sofort
Dauer
Long term
Von
Edelway
Eingestellt
10.05.2013
Projekt-ID:
534474
Vertragsart
Freiberuflich
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