Validation Engineer m/f

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
4 months
Von:
Michael Bailey Associates - Munich
Ort:
Solothurn
Eingestellt:
15.05.2014
Land:
flag_no Schweiz
Projekt-ID:
707352

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Validation Engineer m/fTasks:

- Manages relationships externally and internally.

- Builds cross-functional and cross-departmental support, fostering overall effectiveness

- 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

- 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.

Your Profile:

- 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 a broad technical/educational skills base

Others:

Location: Solothurn

Start date: ASAP

End date: (extension possible)

Hourly rate: negotiable

Contact:

Alexander Berk

ACCOUNT MANAGER PHARMACEUTICAL

Michael Bailey International is acting as an Employment Business in relation to this vacancy.