Qualification & Validation Engineer

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
Long term
Von:
Edelway
Ort:
Ticino
Eingestellt:
10.05.2013
Land:
flag_no Schweiz
Projekt-ID:
534474

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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.