Job description
Yacht (Life Sciences) is offering a position as a Quality Assurance (QA) Specialist at Johnson & Johnson Innovative Medicine in Leiden, the Netherlands.
As part of the QA Quality Systems team, the QA Specialist will coordinate and support the oversight, management, and proper functioning of the quality systems utilized by Johnson & Johnson Innovative Medicine.
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This role requires adherence to Good Manufacturing Practices (GMP) and compliance with quality, regulatory, and Johnson & Johnson's internal standards and guidelines.
The QA Specialist will perform standardized tasks independently, following established procedures and processes, with a primary focus on managing and supporting J&J's quality systems, including documentation and training systems.
Key Responsibilities:
Documentation Management:
· Acts as TruVault SME for system training, support and administration.
· Reviews as SME documents for compliance with GMP regulations; guidance, company standards and other SOPs for impact on patient safety and product quality.
· Acts as SME for internal and external archiving.
· Manages issuance and archival of quality records like test records, external reports, logbooks etc. onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request.
Training Management
· Maintains the Learning Management System (LMS) in support of the operational departments.
· Acts as first point of contact for training for the PDQ department and Departmental Training Delegates (DTD).
· Organizes JVL Site based training, including maintenance of a matrix and coordinates the local training related procedures and ensures yearly training record review for department.
· Supports Department Manager regarding training related responsibilities.
General Quality Systems support
· Can act as Superuser for TruVault and other relevant J&J Quality systems.
· Issuance of Initials to be used on company documents.
