Senior Qualification & Validation Engineer

Bern  ‐ Vor Ort
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Schlagworte

Beschreibung

Senior Qualification & Validation Engineer
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Senior Qualification & Validation Engineer to join them on a long term basis.

Start Date: ASAP
Working Language: English
Rate: Excellent

THE ROLE
*Planning and implementation of qualification/validation activities and projects of new and existing computer systems according
*Internal and external requirements for all departments within the client's EMEA and in particular the EMEA distribution organisation (standard sales, loan & consignment operations in the country affiliates)
*Advisory and support of application owners to build and maintain GDP conform systems
*Approving specific computer system validation documentation and acting as software quality assurance
*Definition of the global CSV framework in collaboration with the regional CSV stakeholders in EMEA
*Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
*Serves as technical expert for the validation process and responsibilities to ensure compliance
*Resolve & manage technical operational problems in the area of expertise
*Suggest and be able to implement innovation and continuous improvement within the validation process
*Review and approve validation master plans, protocols, summary reports and other documentation associated with validations, as appropriate for each validation exercise.
*Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
*Ensure that all validation activities are carried out and reported in a timely manner.
*Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
*Support in the planning, coordination and execution of activities for sales operations affiliate projects (eg design review, qualification of IT systems and infrastructure needs, validation of processes and software, etc.).
*Develop relationships with the operation managers in these countries and acquire a deep understanding of their processes and needs.

YOUR PROFILE
*Working experience in validating computer systems for use in an FDA regulated environment or similar *A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
*An understanding of GDP, Compliance, Validation Practices including regulatory expectations.
*A background in and know-how of distribution/logistics operations is preferred
*Capable of leading and giving direction to validation projects and teams
*Active team member in validation activities methodology/certification requirements

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

Start
keine Angabe
Dauer
Long Term
Von
Edelway
Eingestellt
12.07.2013
Projekt-ID:
566034
Vertragsart
Freiberuflich
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