QUALIFICATION/VALIDATION ENGINEER*IN
AKKA Technologies
Sant Gallen
vor 5 Tg.

Job description

AKKA is the world leader in Engineering and Technological Consulting Services. By accelerating

innovation among its customers, AKKA supports the leading players in the automotive, aerospace, telco

media, industrial, energy, railway, and life science sectors throughout the life cycle of their products,

also made with cutting-edge digital technologies (ADAS, IoT, Big Data, robotics, embedded systems,

machine learning, etc.). We are looking for :

QUALIFICATION / VALIDATION ENGINEER*IN

Tasks

  • Independent planning and execution of work packages and subprojects on
  • qualification / validation (project management and coordination) with focus on computer system validation

  • Execution of risk analyses according to specifications and standards Independent preparation, review and update of qualification and validation documents for routine and complex tasks
  • Consulting for various local and global ( international) projects on the topic of qualification and validation
  • Interface management to IT department, global quality department as well as local production sites
  • Support in local and global / cross-site projects including cost and schedule planning
  • Requirements

  • Successfully completed scientific, engineering / computer science studies or comparable education including further education (FH)
  • Several years of professional experience (>
  • 5 years) especially in the field of qualification and validation with advanced knowledge in computer system validation (CSV);
  • experience in the pharmaceutical industry desirable

  • Very good knowledge of the relevant standards and laws (e.g. GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, etc.
  • and the requirements for qualification and validation of computer systems

  • You have an independent and structured way of working and bring along a high degree of willingness to learn, enthusiasm and motivationYou have a good understanding of technical basics and a distinct affinity for IT
  • Intercultural openness and communication skills are a matter of course for you and you see working in a team as an enrichment
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