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.
Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
Pharmaceutical Recruitment Consultant