We are looking for driven and committed person to a global company headquartered in Gothenburg. Short info about the responsibilities below. It is important that you have experience with FDA, CFR 21, Part 11. Do you find this interesting, feel free to contact Peter Stephan for more information. Tel. 031-722 49 01, email peter.stephan (a) tillvaxtcompagniet.se
- Software validation framework. Develops, initiates, maintains and revises policies and procedures that ensure compliance of IT systems to regulatory requirements. Manages day-to-day operations of the Software Validation Framework. Responds to violation of regulatory requirements with respect to IT.
- Alignment Quality Management. Creates a close dialogue and ensures close collaboration between Global IT and the Compliance Officer in Group Quality.
- Independent review Acts as independent review and evaluation body to ensure that IT systems comply with regulatory requirements, specifically in implementation project and with respect to change control. For both global IT systems, as well as for compliance work performed in the different units around the globe.
- Software validation and change control Supports projects with software validation expertise and ensure complete compliance to regulations. Monitors compliance vulnerability and risks with respect to change control
- Management information & risk management Provides report on a regular basis to make sure the IT Leadership Team is informed of the operation and progress of compliance efforts. Reports risks and vulnerabilities.
- Knowledge transfer Provides training and knowledge transfer to IT staff and IT managers around the globe
- Creates awareness and understanding. Maintains open lines of communication with all relevant decision makes and stakeholders to keep all parties informed of regulatory requirements and regulatory changes. Clear leadership towards Local IT Managers.