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Junior Validation Engineer m/f
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Engineer, Engineering, Support
Projektbeschreibung
VALIDATION ENGINEER M/F
- 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*
- 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..
- Ensure compliance through assisting in audits.
PROFILE:
- 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 Methodology/Certification Requirements.
- Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
Others:
Location: Solothurn
Start date: ASAP
End date: 31.09.2014 (extension possible)
Bei Interesse und wenn Sie nachweislich in den letzten Projekten in diesem Umfeld gearbeitet haben, freuen wir uns über die Zusendung Ihres aussagekräftigen Profils/CV/Projektliste im Word-Format.
Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
Pharmaceutical Recruitment Consultant Michael Bailey International is acting as an Employment Business in relation to this vacancy.
- 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*
- 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..
- Ensure compliance through assisting in audits.
PROFILE:
- 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 Methodology/Certification Requirements.
- Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
Others:
Location: Solothurn
Start date: ASAP
End date: 31.09.2014 (extension possible)
Bei Interesse und wenn Sie nachweislich in den letzten Projekten in diesem Umfeld gearbeitet haben, freuen wir uns über die Zusendung Ihres aussagekräftigen Profils/CV/Projektliste im Word-Format.
Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
Pharmaceutical Recruitment Consultant Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges