Information Technologist, Technical Engineer, Business Administrator as Consultant - Computer System Validation and IT Quality Management (m/f)

Halfmann Goetsch Partner is an international consultancy firm for the healthcare industry with offices in Switzerland, Germany and Singapore. Our company pursues a consequent growth strategy and deals with challenging projects for globally active clients.
To strengthen our team, we are looking for several

Consultants Computer System Validation and IT Quality Management

Site Switzerland, Germany | Function Consultant | Schedule Full-time |
Date 2016.01.01 |

  • Autonomously manage project quality for mid-size and large complex IT project mandates in a regulated environment
  • Managing, creation and reviewing of validation documents
  • Establish validation plans, manage project tollgates, provide quality and validation expertise for project and system life cycle documentation reviews, conduct risk assessments, etc.
  • Identify and pro-actively manage project risks with the customers
  • Ensure full compliance to regulatory (GMP, 21 CFR Part 11, Annex 11) and industry standards (GAMP5)
  • Provide strategic consulting in the areas of Computer System Validation (GxP, CSV), Information Security and Data Privacy
  • University degree or similar in Business Administration, Information Technology or Technical Engineering
  • At least 3-5 years of business experience in IT Computer System Validation (CSV) / IT Quality Management
  • Knowledge and experience in project management
  • Experience with IT environments in the healthcare industry and applicable standards (GAMP 5, Annex 11, 21 CFR Part 11, …)
  • Team player with degree of assertiveness and excellent communication skills
  • English and German are a pre-requisite, other languages are an advantage
  • Consultancy services for international clients within an interesting, growing market and with strategically relevant projects
  • Ownership for shaping and defining new products within our service portfolio
  • Promising opportunities for personal development within a growing company, e.g. leading a team or business unit
Mrs. Carmen Geschke Phone +41 61 544 00 00.
Application to:
or detailed CV and relevant testimonials to

Halfmann Goetsch Partner AG I
St. Alban-Vorstadt 94, CH-4052 Basel
Partner: Thomas Halfmann, Peter Goetsch
While applying for the job please refer to jobvector and use the following reference number: HGP_D_01.2016

About HGP - Halfmann Goetsch Partner AG

HGP ist eine Premium-Unternehmensberatung mit Spezialisierung im Bereich Healthcare Industrie. Wir sind Ihre Partner, wenn es darum geht GMP, Qualitätsmanagement & Compliance Anforderungen zu erfüllen, MES und LEAN erfolgreich einzuführen und Audits zu bestehen. Unsere Kunden sind KMU, globale Konzerne, Hersteller und Zulieferer: Pharmazie- und Biopharmazie-Industrie,...

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