We are currently looking for an IT Quality Specialist to join the QA DSM Execution Systems and IT Quality team based in Hillerød, Denmark.
As a member of the IT Quality team, you’ll help to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of computerized GxP systems.
• Review and approve system development life cycle (SDLC) artefacts, validation and change control documentation for computerized systems supporting GxP processes
• Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported
• Represent IT Quality on assigned computerized systems projects in support of SDLC activities.
• Consult on the authoring and conformance of SDLC deliverables and activities in regards to corporate SOPs, policies and current regulations.
• Provide guidance, training, and support to personnel in their SDLC efforts, to ensure compliance.
• Support develop and implement validation strategies for specific IT systems, focusing on business processes and data integrity.
• Provide quality assurance oversight for system related issues
• Act as a specialist resource to the IT quality team and customer base for interpretation of policy, review and approval of technical documents, and decision making.
• Employ risk-based methodology, where feasible and achievable.
• Knowledge of IT Controls methodologies, including GAMP5 and ITIL
• Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity
• Experience with computerized system validation across GxP systems
• Excellent communication skills, both verbal and written, as well as capable of presenting the right level of information to management
• Knowledge of the IT system development life cycle and software QA in a regulated environment
• Knowledge of general software and database concepts
• Ability to work in a very dynamic environment with a clear sense of urgency.
• Exercises independence in determining objectives and approaches to assignments
• Excellent organizational skills and attention to detail and accuracy
• Must have hands-on IT experience and in-depth knowledge of FDA and International Regulations
• Speak and write English fluently
Bachelor/Master required in Life Sciences or IT related discipline
Please upload your CV and cover letter latest by 27th of October 2019.