Location: Holland, Baarlé-Nassau

We are seeking a Quality Assurance Documentation
Coordinator to manage some quality aspects and projects, as well as to ensure and support overall GxP Conformity and Compliance with the Novartis Quality Management Systems.

This role will work directly with the [QA Systems] team and reports to the [QA Systems Manager].

Key Responsibilities:
• Issuance of controlled documents such as batch manufacturing protocols, cleaning records, validation records, etc., as well as assurance that quality systems documents are archived, such as batch protocols, QC records, maintenance, and calibration records, etcetera, this includes (scanning) paper and electronic archiving.
• Act as main point of contact for IDB’s quality systems, documentation system, and guide colleagues in document creation and editing.
• Acts as main SOP Manager and ensures timely issuance of draft documents and the coordination of document upload, as well as approvals and updates.
• Coordinates and monitors Quality Supports Services from Quality Service Center.
• Coordinates the creation of the (re)design and coordinates the execution of the documentation system for the ongoing site expansion project.
• Works in close collaboration with the Training Responsible Person to ensure proper training arrangements are in place prior to documents becoming effective, ensuring that associates comply with (on the job) GxP training requirements. Furthermore, defines, supports and ensures timely implementation of Quality Systems related CAPA’s, Quality Events, Changes.
• Assists during inspections/audit preparation and during inspections.
• Identifies opportunities and drives continuous improvements across quality systems, e.g. digitalization, standardization projects…
• Act as backup for the QA Officer (Operations) and Training Responsible Person.