JUNIOR VALIDATION ENGINEER m/f

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

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.

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Viele Grüße

Frank Arnold

Pharmaceutical Recruitment Consultant

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
keine Angabe
Dauer
6months
Von
Michael Bailey Associates - Munich
Eingestellt
15.04.2014
Projekt-ID:
695800
Vertragsart
Freiberuflich
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