Consultant
ITL Germany
Wurttemberg, Germany
vor 3 Tg.

Description Role Senior Consultant

Technology / Competency Computer System Validation (CSV), GxP, 21 CFR Part 11, GAMP

Location Munich (Holzkirchen), Germany

The opportunity

Are you someone who wants to collaborate with some of the best talent in the industry? Create innovative and high quality solutions to meet client’s business needs?

If you are interested in being part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded and diversity is respected, this is the place to be.

Job Description

As a Senior Consultant, with an experience of Project Quality Manager (PQM), you should have hands on experience on providing pharma regulatory compliance consulting to development projects with the following objectives,

  • Deliver ISRM services to the client they are part of to help ensure that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance
  • To ensure identified project methodology is followed and deliverables are produced in line with validation approach
  • Driving achievements of the Validation / Quality goals by ensuring that the process and standards defined for the project are followed
  • Required

  • GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge
  • Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation (CSV) concept
  • Preparation for compliance audit, attending meetings and assisting in addressing any issues. Also Supporting Project Manager in risk management activities
  • Able to manage direct relations with stakeholders and project team members.
  • Fluent German and English.
  • Preferred

  • Should have worked in large programs.
  • Worked in Technology projects Like SAP, Conventional technology - (.NET, Java, RDBMS), Digital and Open source - database, development frameworks
  • Worked in projects with Waterfall, Agile and Hybrid - a combination of Agile and Waterfall
  • Personal

    Besides the professional qualifications of the candidates, we place great importance in addition to various forms personality profile. These include :

  • High analytical skills
  • A high degree of initiative and flexibility
  • High customer orientation
  • High quality awareness
  • Excellent verbal and written communication skills
  • Why Infosys

    Infosys is a global leader in technology services and consulting. We enable clients in more than 50 countries to create and execute strategies for their digital transformation.

    From engineering to application development, knowledge management and business process management, we help our clients find the right problems to solve, and to solve these effectively.

    Our team of 190,000+ innovators, across the globe, is differentiated by the imagination, knowledge and experience, across industries and technologies, that we bring to every project we undertake.

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