Beschreibung
Projekt Nr.: A7243Startdatum: sofort
Branche: Dienstleistungsunternehmen
Dauer: 6 Monate mit Option
Einsatzort: Basel Süd
Publiziert am: 17.01.2022
Mögliche Vertragsarten: Berater, Verleih
?https://www.ghrgroup.ch/de/kandidaten/vakanzen/details/orderNr/A7243.html
Beschreibung
Für unseren Kunden suchen wir einen sehr erfahrenen CSV / GMP Validation Specialist wie folgt:
Hauptaufgaben
? Your responsibilities will include Initiation, coordination and monitoring of changes
? Responsible for assessments, defining the scope of validation, and ensuring the test performance
? Coordinating the test phases of software tests
? Responsible for system validation within the scope of IT projects
? Creation and maintenance of validation documents
? Advisory function regarding CSV guidelines
? Preparation and moderation of risk analyses
? Documentation and review according to CSV
? Contact person for Business QA for validation
? Representation of validation during audits
? As a CSV validation specialist at the site, you are jointly responsible for ensuring the validated status of the engineering tool. You will work in a long-standing and agile team consisting of engineers and IT specialists. With your strong understanding of GMP and CSV, you support us not only in the organisation, but also actively during inspections.
Anforderungen
? Completed engineering or scientific studies (e.g. process engineering, electrical engineering, quality assurance, computer scientist with expertise in software engineering and agile project management, etc.) or comparable professional training with several years of professional experience.
? At least 3 years of professional experience in a GMP regulated environment, ideally in the field of Computerised Systems Validation (CSV)
? Professional experience in internal GMP audits or inspections, e.g. accompanying national and international audits by health authorities, is an advantage
? Knowledge of agile methods (Scrum, SAFe, etc.) is an advantage as well as skills in process improvement (e.g. Scrum, )
? Knowledge of ServiceNow is an advantage
? Very good written and spoken German and English skills
Persönlichkeit
? You are a positive thinking, integrity and self-reflective personality with strong communication skills.
? A team-oriented mindset with a view to continuous improvement of processes and the ability to perform consistently at a high level in a constantly changing environment
? Ability and openness to recognise and live the opportunities and benefits of change
? A high level of teamwork and solution orientation as well as a collaborative way of working
WICHTIG
? Remote Regelung -> vor Ort beim Kunden 40-60% / HomeOffice 40-60% je nach Phase des Projektes und COVID Situation
? Es werden Betreibungs- und Strafregister verlangt (Wenn wohnhaft in Deutschland = SCHUFA Auskunft und polizeiliches Führungszeugnis)
Anforderungen
? CSV Spezialist ein Muss
Sprachen
?Englisch sehr gut ein Muss
?Deutsch 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
Direktnr:
E-Mail:
Web: ?http://www.ghrgroup.ch
Schau auch auf der eigenen GHR App für IPhone:
?http://www.ghrgroup.ch/news.html