QA Documentation Specialist
Company: Multinational Biotech company
Location: Amsterdam Area
Start: August 2021 (preferably ASAP)
Currently we are looking for a QA Documentation Specialist who is eager to contribute to the exciting journey in the development of innovative cancer immunotherapies and their conversion to the treatment of patients diagnosed with cancer.
In this position you will work in Quality Assurance team in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible for preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents. You will work closely with Manufacturing Planning to ensure readiness of documents timely and right first time.
Responsibilities (include but are not limited to):
The Quality Systems Document Issuance Specialist will use an Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.
Additional job duties include:
• Responsible for the management of all document issuance and archival processes to support GMP operations.
• Issue effective documents including procedures, test methods, specifications and batch documentation.
• Ensure accuracy and completeness of QA issued documents.
• Identify and escalate compliance gaps across the document management system
• Execute strategic initiatives to improve the document management system.
• Investigate deviations against the document management system and develop effective corrective action plans.
• Provide training to new staff on document management processes and procedures.
• Support audits (internal, external)
• Support projects as needed
• Perform other duties as required.