batch doc coordinator CSC P&L-1700197240W
The Batch Doc & label Coordinator drives the design, packaging and labeling of high quality clinical supplies for studies worldwide. He/she plays a lead role in the Technical Team using his/her expertise in design and labeling to convert the needs of the clinical demand into compliant packaging designs.
Description of the Role
* Maintain detailed knowledge of packaging designs, components, label requirements, randomizations, systems, end-to-end processes and GMP.
* Understands and actively contributes to the role of P&L in the CSC-E2E approach. Strongly interacts with other departments, such as DL, TSM, SCM, within the own area of expertise.
* Establishes priorities, check points and time frames for Batch documentation projects including metrics.
* Will act as a project lead to optimize processes related to batchdoc & label such as training, procedure, Ngencodac,…
* Ability to manage complex compound portfolio (for example: pooled studies, accelerated timelines,…).
* Acting as an expert in the Technical Team on packaging designs and label requirements. Influence the team in taking decisions in line with packaging standards and processes. Act as a single point of contact between the team, the Label Specialists, the Packaging operations unit and Project and Expert Support.
* Develop compliant, user-friendly packaging designs in accordance with the trial design. Evaluate the need for, initiate and coordinate new tool and carton designs in consultation with Project and Expert Support.
* Convert all data with regards to the trial design, packaging design, labeling and randomization into packaging element trees and kit assembly flows. Manage packaging orders in SAP and NGEN CODAC.
* Maintain strong collaborations and relationships with the Technical Team, the Supply Chain Planners, the Label Specialists and the Packaging operations unit to ensure close follow up on milestones contributing to timely availability of all data required and that last-minute changes or issues can be handled adequately.
* Conducts review of packaging documentations and provides feedback as learning opportunity for other colleagues.
Focus and Scope
Responsible for translating the clinical trial design into high quality labeled clinical supplies (large and small molecules and for all phases of clinical trials).
Responsible for process optimization projects, procedures, system requirements, training, and knowledge management.
Critical Experiences Required
* University/bachelor in scientific field or equivalent through experience.
* In depth knowledge on GMP and Good Documentation Practices
* Experience within a clinical packaging unit and knowledge of different equipment
* SAP system knowledge
* Knowledge of planning systems
* Basic knowledge in Office applications (MS Word, MS Excel, MS PowerPoint)
* Fluent in English
* Result and performance driven
* Big picture orientation with attention to details
* Collaboration and Teaming
* Quality and solution mindset
* Strong organizational skills
* Good Communication skills
* Influencing and negotiating skills
* Ability to take initiative and to work independently
* Workflow/Process oriented
What's in it for you…?
"Caring for the world, one person at a time…"
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)