A4197: Senior Validation Engineer (contract)

Zürich  ‐ Vor Ort
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Beschreibung

Projekt Nr.: A4197
Funktion Senior Validation Engineer (contract)
Branche Dienstleistungsunternehmen
Pensum 100%
Arbeitsort Zürich
Antrittstermin asap
Dauer 3 Monate mit Option
Anzahl Stellen 1

Stellenbeschreibung

https://www.ghrgroup.ch/projekt-details/orderNr/A4197.html


Für unseren Kunden suchen wir mehrere sehr erfahrenen Senior Validation Engineer wie folgt:

Primary Tasks and 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
Ensure accuracy and maintenance of the Johnson & Johnson Validation Master List
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
Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Johnson & Johnson Policies and Procedures
Facilitates, encourage and coordinate continuous improvement with respect to validation activities
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Lead by example, inculcating the Credo values in all actions within the workplace

Mustskills Technical:
Knowledge of bespoke validation
Process knowledge and documentation

Mustskills Non-Technical:
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 Re-quirements
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

Nice to have:
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
Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations
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
Sprachen
Sprache mündlich schriftlich Priorität
Englisch sehr gut sehr 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

Tel:
Direktnr:
Fax:
E-Mail:
Web: www.ghrgroup.ch

News - Unsere eigene GHR App für IPhone und Android ist da:
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Start
12.2013
Dauer
3 Monate
(Verlängerung möglich)
Von
Global Human Resources
Eingestellt
05.12.2013
Ansprechpartner:
André van Sprundel
Projekt-ID:
637236
Vertragsart
Freiberuflich
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