ITOT Compliance Specialist

vor 3 Wochen

Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

As a key member of our team at GULP – experts united, you will play a vital role in ensuring the highest standards of quality and compliance in our medical solutions.

Our team in Penzberg is dedicated to pioneering research and development, and we are seeking a highly skilled ITOT Compliance employee to join our dynamic team.

Key responsibilities include:

  • Creation, processing, follow-up and closure of changes, deviations, corrections and preventive measures
  • Performing quality assurance tasks for the unit's QA, IT and automation systems, including associated processes (e.g. archiving, maintenance of master data and maintenance contracts, data integrity)
  • Creation and processing of risk analyses in the quality risk management environment
  • Ensuring operational GMP-relevant documentation (e.g. records management) or the creation and processing of regulations (e.g. content management) in the automation environment
  • Preparation, support and follow-up of audits and inspections
  • Representation of the unit with regard to QA and training topics, as well as the implementation and organization of training in the unit
  • Supporting validation and qualification projects and participating in the establishment of new IT & automation systems

Requirements include:

  • Bachelor, Master, Diploma, e.g. chemical engineer, biotechnology engineer, university degree in computer science, chemistry, biology, biotechnology, process engineering or equivalent technical training with practical experience
  • 4-6 years of professional experience after graduation
  • Experience in quality assurance
  • Experience in a GMP environment is an advantage
  • Experience as (partial) project manager or in-depth knowledge of automation technology or complex IT systems
  • Knowledge of pharmaceutical manufacturing and software development processes
  • Specialized knowledge and limited management tasks or responsibility for sub-areas, ongoing activities, targets and product portfolios
  • Meticulous way of working
  • Fluent German and good English skills

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