TRAINING- EN DOCUMENTATIECOORDINATOR

Job description

Job Description

Requisition ID: 1805675791W

Responsible for, using a risk-based approach, assuring oversight, review, monitoring and support of day to day activities for Document Management and Training Quality Management Systems for Janssen Diagnostics (JDx) business (e.g. LLC and JPNV). In Particular:

·  Ensures the consistent use of EDMS and LMS systems across the business.
·  Coordinate the JDx Document Management and Training systems in alignment with the Quality System strategy, collaborating with Process Owners, authors, reviewers and approvers, trainers and other users of these Systems.
·  Supports processing new or revised GMP documents in the document management system and assigns any applicable training
·  Ensures users of the system are trained accordingly and have the corresponding access rights.
·  Perform LMS transactions including user and item management, reports generation and maintenance of curricula and completions as needed.
·  Ensures the training curricula and the user groups are up-to-date, the training assignments are performed according to the training curricula.
·  Ensures the procedural documents are maintained up-to-date in the system, according to the applicable periodic review and document management process (incl. change control process for procedural documents).
·  Collects and provides metrics for Training and Document Management processes.
·  Assists during audits/inspections in the front- and back room with requests for procedural documents and/or training.
·  Resolves issues related to the EDMS, specific documents and document management practices in general. When appropriate, escalates issues to Manager, Quality and Document Control
·  Supports JDx Quality for document management and training Quality Issues, CAPAs and change requests.
Employee Specific Additional task:
·  Supports key projects and initiatives for JDx to standardize and harmonize quality systems such as the Doc management process to align with the Quality System strategy, collaborating with business partners and project teams.
·  Provides support to procedural documentation and/or training councils (e.g., Cross-Pharma Council, Pharm Sector Training Council), as needed
·  Assists with the deployment of Enterprise Standards and Cross Pharm documents as a Local Process Owner by providing input into document reviews and gap assessments.
·  Coordinates the JDX_JPNV record management process. Assist with clean outs, shipping boxes for archival, updating the Record Retention Schedule. Assist users with understanding the retention period of documents/records.

Desired profile

Qualifications

·  A combination of an Associate degree with experience in a GMP regulated work environment
·  Experience in a pharmaceutical or medical device quality environment with R&D laboratory/analytical science background is preferred
·  Knowledge of current and applicable GMP, CAP/CLIA and International Organization of standardization (ISO) regulations are required
·  Candidate should possess good verbal and written communication skills, strong leadership skills, and ability to multi-task, and flexibility to shifting job priorities.
·  Must be proficient in Microsoft Office tools for communication, reporting, and data analysis (I.e. Word, Excel, and PowerPoint)
·  Experience with electronic document management systems and learning management systems is an asset
·  Experience working in cross functional and cross site teams
Primary Location
Belgium-Antwerp-Beerse
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Administration
Requisition ID
1805675791W