Qualification & Validation Engineer Job in Switzerland

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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

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