LEDP 3DX Data Steward
A-SAP
Contact person: Nasar Rehman
Frankfurt, Germany
Description
The project is to start as soon as possible, for 1 year at least, remote possible (with occasional travels to Frankfurt), German + English is a must.
Skills and responsibilities:
Core Accountability
The Site Implementation Key User is accountable for realizing the LEDP (3DX) tool usage at the site.
He/she acts as the primary implementation specialist for the local MSAT organization and the global LEDP function to introduce detailed process information into the platform.
Scope
In scope
- User support and enablement for the tool for Frankfurt /InsuLINK project needs
- Tool adoption and usage consistency in Frankfurt site
- Site readiness for LEDP releases
- Understand all needs of stakeholders
- Understand the technical background, capabilities and requirements of 3DX/LEDP
- LEDP functional usage
- Understand the different use cases and the overlaps
- Understand differences in insulin manufacturing process and important data structures
- Collect all relevant process information and bring them together in a harmonized layout
- Restructure the process information into an overall applicable form
- Import and integrate the process information into the LEDP platform to launch business processes
Out of scope
- First-line functional support and issue qualification (responsibility of LEDP core team)
- Decision-making on global LEDP roadmap or architecture
Key Responsibilities
LEDP Site Process Information Owner
- Acts as collection point of process information and systems for all stakeholders
- Interfaces with:
- Legacy operations team
- InsuLINK Team
- LEDP global team
- Site Launch Leaders (tool usage & deployments)
- Digital LEDP Product Owner
- Represent the special needs of all stakeholders and product stewards for Frankfurt/InsuLINK LEDP usage
- Ensures the implementation of all relevant information and the correctness
LEDP Usage monitoring
- Ensure LEDP is used according to defined functional usage guidelines (defined by LEDP global tem)
- Promotes system-based execution and limits off-tool workarounds
- Assess correct usage of:
- Workflows / Version approvals
- Status updates
- Data fields and attachments
User Enablement & Access Support
- Ensure users:
- Make correct access and roles request in LEDP
- Approve Access request for site users in ServiceNow
- Coordinates:
- Onboarding of new LEDP users at site level
- Understand how to use the tool for their responsibilities
- Refresher training when recurring usage issues arise
- Acts as a local coach for LEDP usage.
LEDP Technical Accuracy and Facility Harmonization Management
- Participate in project meetings
- Collect and work out comparable process information of different project facilities
- Work out a naming convention and function based on LEDP-functionalities in accordance with global data & standardization guidelines, with support from Global Launch Engine team
- Perform exploration tests
- Ensure correct working while comparing different facilities
- Risk assessment of impact if comparing fails
- Implement and import all relevant process information for different facilities
- Ensure the completeness and data integrity of the information
- Communicates tool-related impacts to LEDP global key users
Feedback & Continuous Tool Improvement
- Collects structured feedback on:
- Usability
- Missing functionalities
- Adoption barriers
- Submits and tracks:
- Improvement requests
- Defect reports
- Shares site-level feedback with global LEDP teams
Act as a support of Data steward for data entry when required
Profile
- Experienced with LEDP/3DX implementation
- Able to restructure big amount of data and bring them organized in a harmonized way for all different facilities in the LEDP/3DX platform
- Collaborative mindset with the LEDP/3DX network
- Experienced with facility fit and facility harmonization
- Ideally: Experienced in GxP data management in a DS pharmaceutical environment
- Comfortable with digital platforms and structured workflows
- Able to manage many stakeholders focusing on specific target
- Able to construct a strong network at site production/operation level & global level
- Interested in personal development by supporting different functions