senior consultant computer system validation (m/w).

Job description.

 

As Senior Computer Validation Specialist you independently perform CVS projects in an international environment. You support projects or programs as Validation Lead, develop validation strategies, and play a key role for our various customers in the pharmaceutical and medical technology industries. Your place of work is primarily at our customers‘ locations, while our headquarters in Athens (Greece) or Tägerwilen (Switzerland) serve as central offices.

 

 

Your key responsibilities.

 

     Independent implementation of projects in the fields of IT / GxP Compliance, and Computer System Validation (CSV)

     Leading role in Quality /Compliance Management as part of national and international projects teams - on-site at customers‘ locations from the Life Science Industry

     Managing role in customer projects - in particular validation of software-systems in accordance with regulatory compliance and through implementation of new tools - especially for SAP applications

     Execution of training and coaching in the areas of Computer System Validation (CSV), IT Compliance, and Test Management

     Integration, instruction, and management of our (Junior) Consultants during the course of projects

     Development of profound strategic relationships with our project partners and establishment as a Single Point of Contact

     Expansion of our customer network and support of our established customer base

 

 

Your profile.  

 

     Bachelor‘s degree in natural sciences, business administration or computer sciences

     Professional experience in implementation of complex validation projects, in particular IT Compliance /CSV (with knowledge of relevant regulatory compliances and tools in the areas of GxP and / or medical technology)

     Professional Experience in the area of Compliance (e.g. IT Compliance, CAPA Management, Change or Release Management) and knowledge of standards (e.g. 21 CFR 820, 21 CFR Part 11, ISO 14971)

     Interest in project acquisition

     Systematic approach and good analytical skills

     High level of proficiency of the English language for effective communication with our national and international projects

     Excellent analytical thinking and high abstraction capabilities, quick perception, strong persuasive skills and creative power.

     Excellent customer focus, strong social and networking skills

     Strong interpersonal skills and high enthusiasm

     Flexibility and mobility