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    Qualification & Validation Engineer Job in Switzerland

    Pauwels Consulting staffs, manages and executes projects and we recruit top experts for leading companies in Engineering, Pharma and IT. How may we help you?

    Qualification & Validation Engineer Job Description

    Pauwels Consulting is currently looking for an Italian speaking Qualification & Validation Engineer to provide support to the validation activities associated with equipment and business applications for one of our pharmaceutical partners in Switzerland. The Qualification & Validation Engineer ensures that all compliance issues and requirements of the Company Validation Policies and Procedures are addressed.


    The main responsibilities of the Qualification & Validation Engineer are:
     

    • Managing Complexity/Technical Accountability
    • Serves as technical expert for the validation process and responsibilities to ensure compliance
    • Continuous Learning/Managing Risks
    • Resolves & manages technical operational problems in area of expertise
    • Suggest and sometimes may implement innovation and continuous improvement within the validation process
    • Implements initiatives in the validation process that will deliver customer value at lowest cost
    • Facilitates successful team behavior within Quality Systems and across functional areas
    • Manages relationships externally and internally
    • Builds cross-functional and cross-departmental support, fostering overall effectiveness
    • Fosters harmony within Quality Systems
    • Influences and persuades so as to bring about technical and process improvements
    • Ensure accuracy and maintenance of the Company Validation Master List
    • Create 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
    • Ensure compliance through assisting in audits
    • Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with the company Policies and Procedures
    • Facilitates, encourage and coordinate continuous improvement with respect to validation activities
    • Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment

    Qualification & Validation Engineer Job Requirements

    What does Pauwels Consulting require of the Qualification & Validation Engineer:
     

    • A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
    • Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
    • Minimum of 2 years working in a regulated environment, a minimum 1 of which has been spent carrying out validation and/or testing activities
    • Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations
    • Language Skills: English & Italian fluent
    • Knowledge of bespoke validation
    • 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
    • Must be able to lead and give direction to Validation Projects and Teams
    • Individual must also be an active team member in Validation activities

    Qualification & Validation Engineer Application Information

    What can you expect from Pauwels Consulting.

    A responsible position in a leading international company.
    Personal development opportunity’s through learning on the job and additional external trainings.
    You can expect a market oriented compensation, including a wide range of fringe benefits


    Please apply with your CV and cover letter by the 'apply' button below

    Qualification & Validation Engineer Summary

    Education Backgrounds: Business Engineering
    Environmental Engineering
    Healthcare Science
    Specialties: HSE(Q) Management
    Pharmaceutics
    Process Engineering
    Quality Engineering
    Testing
    Education Level: Undergraduate (Bachelors)
    Postgraduate (Masters)
    Doctorate (PH.D)
    Experience: 10 - 15 years
    2 - 5 years
    5 - 10 Years
    Languages spoken: English
    Italian
    Job Location: , Switzerland

    Apply

    Pauwels Consulting

    Gent, Belgium
    Gertjan Van Riet
    +32 9 324 70 80
    View Company Profile More Jobs with

    Type: Job

    Deadline: 21st October 2013

    Job reference (ID): 6556

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