Description
Description
SaaS Compliance and Validation senior analyst
In light of the Janssen CRM SaaS program and supporting a successful implementation and roll-out in the different functional areas, Janssen EMEA I/T is currently looking for Compliance and Validation senior analyst.
Main objectives will be:
Assist team in implementation and setup of scrum/agile development life cycle
Produce and own compliance documentation for the project
Monitor and assist in system validation
Project/Department Description and responsibilities
Compliance and Vaildation role will be part of the Pharma EMEA Janssen Organization Sales & Marketing (S&M) Regional Initiatives (RI) group. This position will report to program manager. The S&M RI group is in charge for supporting EMEA solutions for the sales and marketing organization, including the Pharma EMEA CRM and DWH systems being used by more than 3000 users across different geographies in EMEA.
The S&M RI group is promoting the standardization and leveraging solutions across different markets. As part of this role, the S&M RI team communicates best practices across the different geographies and is in charge for enhancing the IT capabilities and services for the different processes supported. The S&M RI team is also responsible for analysing requirements and producing the functional specifications to satisfy requirements from EMEA and OpCos key users.
Additionally, the S&M RI group is supporting the deployment of the different S&M processes in the different operating companies across EMEA, closely collaborating with local IT and business partners, providing training to key users.
Environment Development Tool(s) and Platform(s)
SCRUM/Agile tools that support user stories, product backlog and testing in big scale SaaS projects
Salesforce.com project experience
Primary Tasks and responsibilities
Monitor and control compliance and validation
Produce and manage relevant compliance and documentation
Review and validate project documentation and procedures
Support testing and validation phases, managing and support business analyst to generate test scripts
Manage and document results of different test phases
Qualification planning and cooperation with project teams to ensure qualification activities are performed and reporting of project compliance status
Maintenance and review of qualification documents and coordination of corrective actions
Technical profile requirements
Know and understand compliance and data privacy areas in the context of pharmaceutical business
Expertise on managing big scale project through SCRUM/Agile methodology
SDLC/ITIL certification is a plus
knowledge of testing practices, (experience with HP Quality Centre is a plus)
Good Manufacturing/Clinical/Laboratory Practices (GxP) regulation, you have worked in environments that are subject to GxP and participated in activities that ensure GxP compliance (+3 year)
Easily analyze processes, draw flow chart diagrams and describe processes in clear language. You have excellent (technical) writing skills (+3 years)
Excellent ability to process and analyze data in Microsoft Office tools like Excel and SharePoint (+3 years)