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Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

icon building Company : Midas Pharma Gmbh
icon briefcase Job Type : Full Time
icon geo-alt Ingelheim

Number of Applicants

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Job Description - Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

  • Planning, coordinating and implementing the validation of computerised systems in accordance with applicable regulations
  • Ensuring compliance with legal requirements during all phases of the validation of computerised systems
  • Management of all documents arising from validation projects
  • Implementation of risk management in the computerised validation environment (CSV)
  • Preparation of final validation reports
  • Ensuring data and system security
  • First point of contact for all questions relating to validation processes
  • Planning, support and monitoring of validation, qualification and calibration measures
  • Coordination and administration of deviation management
  • Preparation and review of GMP-related documents
  • Degree in computer science or natural sciences and several years of professional experience in quality management in the pharmaceutical industry 
  • Sound knowledge of the validation of computerised systems in the pharmaceutical industry
  • You are familiar with the current GMP requirements and guidelines for the validation of computerised systems (GAMP5)
  • High organisational skills, result-oriented way of working and quick adaptability
  • Good communication skills, enjoy interdisciplinary work
  • Very good knowledge of German and English
  • Midas Pharma is a well-established and renowned family business that offers you a personal and appreciative working atmosphere in addition to the security of over 30 years of business
  • Our workplaces are not open-plan offices, but personal offices where you can also retreat from time to time, equipped with the latest technology and ergonomic office furniture
  • Our organization enables you to make quick decisions - a key factor of our success
  • Due to our flat hierarchies, there is a very close interaction at Midas - personal and professional - it is not uncommon for management to be involved in interdisciplinary projects
  • We are looking for you as a personality and want you to contribute authentically - in turn, we encourage this by giving you great freedom for creativity and independence
  • At Midas, all paths to personal and professional development are open to you - various support programs as well as assignments abroad are just a few possibilities
Original job Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV) posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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