Beschreibung
Projekt Nr.: A3944Funktion Qualification and Validation Engineer (contract)
Branche Medizintechnikunternehmen
Pensum 100%
Arbeitsort Bern Ost
Antrittstermin asap
Dauer 6 Monate mit Option
Anzahl Stellen 3
Stellenbeschreibung
https://www.ghrgroup.ch/projekt-details/orderNr/A3944.html
Für unseren Kunden suchen wir mehrere sehr erfahrenen Qualification and Validation Engineer wie folgt:
Project Description:
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements.
Main Responsibilities:
Managing Complexity/Technical Accountability
Serves as technical expert for the Validation process and responsibilities to ensure compliance
Continuous Learning/Managing Risk
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.
Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation as-sociated with validations, as appropriate for each validation exercise
Must-Skills:
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.
Must be able to lead and give direction to Validation Projects and Teams.
Nice to have:
Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
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.
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.
Diverse Tätigkeiten gemäss Projektleiter
Anforderungen
IT Profil Priorität
Validation Engineer ein Muss
Qualification Engineer ein Muss
Sprachen
Sprache mündlich schriftlich Priorität
Englisch gut gut ein Muss
Deutsch sehr gut sehr gut ein Muss
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG
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Web: www.ghrgroup.ch
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