You are accountable for coordinating and supporting the activities related to PV audits and inspections in Global Safety and affiliates, which includes coordination of audit/inspection preparation, on-site support during the inspection, and coordination of response preparation and submission to the Competent Authorities.
In order to face the development of our activities, we are currently seeking a Regulatory Affairs Senior Specialist to support the Regulatory Affairs activities related to the development of new technology based allergy immunotherapy products.
Work in a safe and environmentally responsible manner. Operating, monitoring and controlling equipment, systems and processes associated with the Vial/Cartridge filling and inspection lines. Achieving production goals. Maintaining aseptic areas and performing sensitization and environmental monitoring.
The Quality Assurance Specialist will be working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP. He / she will also support the development of GMP training packages and delivery of training. Under the direction of the reporting manager, continuously improve QA and Compliance systems, strengthen quality awareness...
Lead and coordinate the document control function to ensure version control, traceability/logging, and location/security of documents, including electronic (and paper, if applicable) archival/systems management.
Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review and review of Annual product Reviews. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.
Support site QA head in setting up a robust Quality Management System for our company in EU, meeting EU standards, in line with and leveraging from the company US QMS. The objective is to obtain a GMP license for the company EU activities for its GMP activities.
Responsible for provide NNRCC office & laboratory with reliable and stable HVAC, BMS, electrical, purified water supply, waste water processing, and special gas supply systems, etc. Responsible for the operation of animal facility.
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