Trackwise Specialist
Arjo AB Publ / Datajobb / Malmö
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hela Sverige Visa alla jobb hos Arjo AB Publ i Malmö We are recruiting a Trackwise Specialist, who will be a key player in the new Quality set up within Arjo, interfacing with key stakeholders inside and outside the organization. This is a one time opportunity of taking part in forming this new listed company.
This is an ideal role for an individual looking for a challenge where you have the possibility to improve and develop the using of the system Trackwise within the organization. You will have to take a big responsibility and take the lead and drive this process. The Trackwise specialist will be the intermediator between Process Owners, our Quality Managers and IT.
The Position
This role is responsible for developing, improving and building processes in TrackWise from a regulatory and business perspective.
Among your main responsibilities and tasks will be:
Change Management
• Chair Change Advisory Board meetings for TrackWise.
• Responsible for evaluation of Change Requests (impact assessment and prioritization from a regulatory and business perspective)
Internal Project lead for TW projects (new processes or major changes)
• Business Analyst translating business needs into TrackWise processes.
• Establishment of requirement specifications based on regulatory requirements and input from the organization / process owners and users.
• Planning of / participation in validation (VP, DS, FS, IQ/OQ/PQ protocols, test scripts, test execution, IQ/OQ/PQ reports, VR, TM).
• Maintenance of system documentation.
• User training incl. creation and maintenance of training material
• Configuration changes (with use of consultants where needed)
Computer Systems Validation (CSV)
• Manage computerized systems validation of IT systems owned by the Quality Regulatory function, e.g. TrackWise and Advantum.
• Participate in IS/IT and other projects for development and change of computer systems handling gGxP data.
• Provide guidance on validation work and documentation.
• Review and approve the various elements of the CSV packages.
Dialogue with and coordination of all stakeholders when developing and improving the TrackWise system:
• Global IT responsible for IT policies, 1st line support, technical maintenance and administration.
• Various functions within the Arjo organization (QRC, Supply Chain, SSUs, etc.)
• Consultants
• Vendor (Sparta Systems)
Quality System Duties and Responsibilities:
• Support the Quality Applications team with development and management of quality application and related procedures.
• Support IT with 2nd line support related to TrackWise.
• Build Quality into all aspects of the work by maintaining compliance to all quality requirements.
The position is located in Malmö, Sweden. The role requires international travel, approximately around 10%. You will be reporting to the Director Quality Applications.
The Ideal Candidate
We are looking for a person with this background:
• Master 's or Bachelor's Degree in any field of study, preferably IT or Engineering.
• Experience in Quality Management or related functions within Life Science, HealthCare or other regulated environment.
• Experience in computerized systems validation.
• Experience in developing and working with IT systems e.g. TrackWise, databases, ERP systems, Microsoft Office package.
• Experience with project management.
• Experience from conducting training courses & presentations.
• Good knowledge in applicable regulations and standards, e.g. ISO 9001, ISO 13485, FDAs 21 CFR Part 820 and 11, GAMP.
• Fluent in English.
• Ability to translate standards and regulatory requirements to the appropriate level for the organization.
As a person you are a good communicator, intercultural and have great networking skills. You are solution oriented and have the ability to work independently in a well-structured and systematic manner.
Arjo is a globally minded company with a Swedish heritage, where a thriving international environment is driven by Swedish leadership culture. As a company that puts people at the heart of everything we do, Arjo employees are our partners in our mission to improve lives.
Explore challenging and rewarding careers in a wide range of specialties across our global network.
Publiceringsdatum2018-01-15Så ansöker duSista dag att ansöka är 2018-01-31
Ange följande referens när du ansöker: Trackwise Specialist
Klicka på denna länk för att göra din ansökanFöretagArjo AB Publ
AdressArjo AB Publ
Hans Michelsensgatan 10
21120 Malmö
KontorsadressHans Michelsensgatan 10
Jobbnummer 3902557
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