IT Project Manager - CSV & Compliance
MAM GruppePosted on 04/Nov/2019
- Information Technology
- Hamburg, Germany
- Planning and execution of global projects int he field of Computer Systems Validation (CSV) and other IT compliance projects.
- Structural development and content maintenance of the CSV Systems Inventories and the gloval validation master plan.
- Analysis and further development of the formal IT frameworks in close cooperation with the organisation's quality departments, as well as accompanying audits in the IT area.
- Assisting in the continuous quality assurance of the organisation's validation, basic methods and procedures.
- Support in IT process management with respect to GMP and other regulatory requirements.
- Completed degree in Economics or Applied Computer Science, Business Engineering or Electrical Engineering/Mechanical Engineering with IT focus.
- Additional qualification as quality manager or quality management and GMP basics (ISO 13485 and 21 CFR Part 830 Quality Systems Regulations/Validation).
- Versatile experience in the introduction of IT systems and in the monitoring of audits.
- Very good written and verbal skills in English and German.
- Strong teamwork and communication skills.
- Strong customer and result orientation.